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  • Dispositivo 1149
  • Fabricante 31827
  • Evento 1201
  • Implante 0
Retiro De Equipo (Recall) de BD, Brucella Postive Control Antiserum (AMS)
  • Tipo de evento
    Recall
  • ID del evento
    30443
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0322-05
  • Fecha de inicio del evento
    2004-10-20
  • Fecha de publicación del evento
    2004-12-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2005-02-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35887
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Antisera, Fluorescent, Brucella Spp. - Product Code GSM
  • Causa
    Febrile antigens and control antisera that were released prior to august 2003 contained the 12/2000 revised insert that had incorrect testing instructions.
  • Acción
    Consignees were notified by letter beginning 10/20/2004.
Retiro De Equipo (Recall) de BD, Febrile Antigen Negative Control
  • Tipo de evento
    Recall
  • ID del evento
    30443
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0323-05
  • Fecha de inicio del evento
    2004-10-20
  • Fecha de publicación del evento
    2004-12-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2005-02-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35888
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Antisera, Fluorescent, Brucella Spp. - Product Code GSM
  • Causa
    Febrile antigens and control antisera that were released prior to august 2003 contained the 12/2000 revised insert that had incorrect testing instructions.
  • Acción
    Consignees were notified by letter beginning 10/20/2004.
Retiro De Equipo (Recall) de Phoenix
  • Tipo de evento
    Recall
  • ID del evento
    30445
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0268-05
  • Fecha de inicio del evento
    2004-10-29
  • Fecha de publicación del evento
    2004-11-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2005-01-31
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35890
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    System, Test, Automated, Antimicrobial Susceptibility, Short Incubation - Product Code LON
  • Causa
    The foil pouch containing an in vitro diagnostic test kit for bacteria identification in patient samples may be defective and cause incorrect patient results.
  • Acción
    BD Diagnostic Systems notified end users by letter dated October 2004. The firm''s sales representatives delivered the letters initially on 10/29/04. The letter advises end users to examine identified lots for defects using a diagram provided with the notification and discard any suspect product for replacement. A response form is included with the notification.
Retiro De Equipo (Recall) de ARCHITECT STAT Myoglobin Calibrators
  • Tipo de evento
    Recall
  • ID del evento
    33845
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0400-06
  • Fecha de inicio del evento
    2005-10-17
  • Fecha de publicación del evento
    2006-01-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2006-05-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=42539
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Myoglobin, Antigen, Antiserum, Control - Product Code DDR
  • Causa
    Some of the kits were shipped at the incorrect shipping temperature. they were shipped ambient, but should have been shipped frozen.
  • Acción
    Abbott telephoned the laboratory end users on 10/17/05, informing them that Abbott discovered that ARCHITECT STAT Myoglobin Calibrators, lot V96128, were shipped to their facilities using the incorrect shipping conditions between August 29th and September 20th 2005. The kits should have been shipped frozen, but were shipped ambient. The error has been corrected. All shipments made after September 21, 2005 have been shipped correctly. Any data generated to date using this kit of calibrators is acceptable, providing that a valid calibration was achieved and product labeling was followed. However, long term use of this kit may result in calibration failures or controls out of range. The accounts were requested to mark the kit(s) of this lot currently in inventory to distinguish them from the replacement kit(s) Abbott will be sending to them. As a precaution, Abbott requested the labs to discontinue use of these kits and destroy them the replacement kits are received.
Retiro De Equipo (Recall) de Access
  • Tipo de evento
    Recall
  • ID del evento
    37065
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0417-2007
  • Fecha de inicio del evento
    2006-10-26
  • Fecha de publicación del evento
    2007-02-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-04-30
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49841
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    in vitro diagnostic - Product Code DDC
  • Causa
    Low end imprecision affecting both s0 calibrators and patient samples which can lead to inaccurate low level patient results when using the access thyroglobulin antibody assay.
  • Acción
    A Product Corrective Action (PCA) letter was mailed on Oct 27, 2006 to all Thyroglobulin Antibody customers. They are informed that there has been an increase in customer feedback regarding low end imprecision affecting both S0 calibrators and patient samples, which can lead to inaccurate low level patient results when using the Access Thyroglobulin Antibody assay. The letter informs the customer that the firm recommends that they use an alternate method for testing TgAb. (Letter was sent by US mail). Customers are asked to complete and return the enclosed response form within 10 days.
Retiro De Equipo (Recall) de MONOLISA
  • Tipo de evento
    Recall
  • ID del evento
    44881
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0065-2008
  • Fecha de inicio del evento
    2007-09-05
  • Fecha de publicación del evento
    2007-10-31
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2007-11-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=64469
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Anti-HBc IGM EIA kit, - Product Code LOM
  • Causa
    Incorrect instruction: the package insert states to add 100l of conjugate; it should state to add 100ul.
  • Acción
    On 9/5/07 a letter titled "IMPORTANT PRODUCT INFORMATION" was sent to customers advising them of the issue and requesting customers make a note of the correction in their laboratory procedures and/or any existing copies of the package insert. On 9/19/07 the firm sent a second letter (dated 9/18/07) via DHL titled "URGENT PRODUCT CORRECTION" and supplied a corrected package insert to replace the original insert sent.
Retiro De Equipo (Recall) de ARCHITECT i System Assay CDROM WW (excluding USA accounts)
  • Tipo de evento
    Recall
  • ID del evento
    45397
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0299-2008
  • Fecha de inicio del evento
    2007-09-18
  • Fecha de publicación del evento
    2008-01-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-11-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=65375
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Chemiluminescent Microparticle Immunoassay (CMIA) - Product Code LOJ
  • Causa
    The lower limit flag for auto-dilution protocol 3 (amniotic fluid) was set too low (15 ng/ml) for the architect afp assay file for the architect afp non-u.S. product. the assay labeling indicates that the limit flag should be set no lower than 20 ng/ml.
  • Acción
    Abbott affiliates were e-mailed copies of the Product Correction (Immediate Action Required) Recall Letter on 9/18/07 for translation where needed and dissemination to their ARCHITECT accounts who have the affected assay CD-ROMs. Each Abbott international organization will be responsible for contacting customers and determining the method of effectiveness checks based on their country requirements. Abbott sent Product Correction, Immediate Action Required letters dated 18 September 2007 to all active non-U.S. ARCHITECT customers who have the affected assay CD-ROMs. The end users were informed that current AFP file has been updated on a new ARCHITECT I Assay CD-ROM (LN 6E59, version 24). The Low-Linearity flag threshold for the Amino 1:50 dilution has changed from 15 ng/mL to 20 ng/mL for consistency with overall assay sensitivity. The accounts were advised to install the updated version of the current ARCHITECT AFP assay when they receive the version 24 ARCHITECT I Assay CD-ROM. The accounts were requested to keep a copy of the letter on file. The accounts were requested to complete the customer reply form, indicating that the letter was received, understood and disseminated to the laboratory manager/supervisor responsible for Architect testing, and fax it to Abbott by 9/28/07 at 1-800-777-0051.
Retiro De Equipo (Recall) de LyfoCults
  • Tipo de evento
    Recall
  • ID del evento
    45530
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0721-2008
  • Fecha de inicio del evento
    2007-10-15
  • Fecha de publicación del evento
    2008-02-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-04-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=65741
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Quality Control kit for culture media - Product Code JTR
  • Causa
    Incorrect micro-organism-- quality control in-vitro diagnostic test was manufactured with cryptococcus neoformans (atcc 76484) instead of haemophilus parainfluenzae (atcc 7901).
  • Acción
    On 10/15/2007, firm notified consignees by telephone. A follow up letter dated 10/26/07, was faxed to customers instructing them to discontinue use and discard remaining inventory on site as a biohazardous material. Consignees were requested to fax back response indicating the amount of product they had on hand at time of notification.
Retiro De Equipo (Recall) de LyfoCults (IDS Rapid NH QC Set)
  • Tipo de evento
    Recall
  • ID del evento
    45530
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0723-2008
  • Fecha de inicio del evento
    2007-10-15
  • Fecha de publicación del evento
    2008-02-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-04-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66395
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Quality Control kit for culture media - Product Code JTR
  • Causa
    Incorrect micro-organism-- .Quality control in-vitro diagnostic test was manufactured with cryptococcus neoformans (atcc 76484) instead of haemophilus parainfluenzae (atcc 7901).
  • Acción
    On 10/15/2007, firm notified consignees by telephone. A follow up letter dated 10/26/07, was faxed to customers instructing them to discontinue use and discard remaining inventory on site as a biohazardous material. Consignees were requested to fax back response indicating the amount of product they had on hand at time of notification.
Retiro De Equipo (Recall) de Remel RapID Inoculation Fluid 2ML
  • Tipo de evento
    Recall
  • ID del evento
    46801
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1625-2008
  • Fecha de inicio del evento
    2007-10-23
  • Fecha de publicación del evento
    2008-05-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-07-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=70849
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Microorganism differentiation and identification device - Product Code LIB
  • Causa
    Failure to produce reaction: use of the product with various rapid identification systems panels may exhibit poor or no reactions.
  • Acción
    Consignees were notified by an Important Medical Device Customer Advisory Notice on 10/23/07. The letter instructs users to review inventory and discard any affected products. The letter also instructs users to return a product inventory checklist by 11/23/07. For additional information, contact 1-800-447-3641.
Retiro De Equipo (Recall) de KASSAY Alpha1 Microglobulin Reagent
  • Tipo de evento
    Recall
  • ID del evento
    50074
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0923-2011
  • Fecha de inicio del evento
    2008-09-17
  • Fecha de publicación del evento
    2011-01-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-01-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74651
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Alpha-1 microglobulin, antigen, antiserum, control - Product Code MGA
  • Causa
    Standardization of the reagent performance data did not match the standardization used to assign the calibrator values.
  • Acción
    Kamiya Biomedical Company, LLC sent an urgent medical Device Recall letter dated September 17, 2008, and the corrected package insert via e-mail. . The letter identified the product, the problem, and the action the customer should take. Customers were instructed to replace their previous package inserts with the corrected version and asked to sign and FAX the letter back once that had been completed. As one customer is also a distributor, the recalling firm told the this distributor's representative to advise their single customer of this correction and replace the package insert, and return the signed letter back to the firm. On September 22, 2008, both customers were contacted by phone and reminded to fax the signed letters once completed. For questions regarding this recall call 1-800-222-0342.
Retiro De Equipo (Recall) de IsMeasles IgG Enzyme Immunoassay Test Kit
  • Tipo de evento
    Recall
  • ID del evento
    50162
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0607-2009
  • Fecha de inicio del evento
    2008-10-10
  • Fecha de publicación del evento
    2009-01-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-05-12
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74884
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Rubeola (measles) virus serological reagents. - Product Code LJB
  • Causa
    Possible false-negative test results: the sample a diluent lot # 50768 assigned to is-measles igg lot #'s 41108 and 41108b has higher conductivity than normal, which can sporadically interfere with the mago plus/aptus sensing of and picking up of samples. as a result, if the sample is not picked up/processed, it could lead to the possibility of obtaining false negative results in some cases.
  • Acción
    Notification of all domestic customers via Certified Mail. Notification of the one international customer via Federal Express.
Retiro De Equipo (Recall) de Dryspot (R) Staphytect Plus
  • Tipo de evento
    Recall
  • ID del evento
    50224
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1008-2009
  • Fecha de inicio del evento
    2008-10-07
  • Fecha de publicación del evento
    2009-03-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2009-07-30
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=75004
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Staphylococcus Aureus Screening Kit - Product Code JWX
  • Causa
    Control and test wells are reversed on some of the reaction cards.
  • Acción
    The recalling firm issued Important Medical Device Customer Advisory Notice letters dated 10/7/08 via regular mail to their customers explaining the reason for recall. The letter requested that they review their inventory for the product lots indicated in the letter; discard all of the lot remaining in their inventory; complete and return the Product Inventory Checklist.
Retiro De Equipo (Recall) de BD Vacutainer Urine Complete Kit
  • Tipo de evento
    Recall
  • ID del evento
    53650
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1024-2010
  • Fecha de inicio del evento
    2009-10-12
  • Fecha de publicación del evento
    2010-03-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-03-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86266
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Culture media, non-propagating transport - Product Code JSM
  • Causa
    A small amount of discoloration was noted on towelettes included in bd vacutainer urine collection kits. the entire kit components retain sterile interiors and no viable growth was detected on the towelettes.
  • Acción
    Recall notification letters were sent on 10/12/09 with return receipt requested. Customers were advised to contact your SO Sales Consultant for additional information, via e-mail at Vacutainer_TechServices@SD.com or via telephone at 1-800-6310174.
Retiro De Equipo (Recall) de BD Vacutainer Urine Complete Kit
  • Tipo de evento
    Recall
  • ID del evento
    53650
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1025-2010
  • Fecha de inicio del evento
    2009-10-12
  • Fecha de publicación del evento
    2010-03-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-03-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86267
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Culture media, non-propagating transport - Product Code JSM
  • Causa
    A small amount of discoloration was noted on towelettes included in bd vacutainer urine collection kits. the entire kit components retain sterile interiors and no viable growth was detected on the towelettes.
  • Acción
    Recall notification letters were sent on 10/12/09 with return receipt requested. Customers were advised to contact your SO Sales Consultant for additional information, via e-mail at Vacutainer_TechServices@SD.com or via telephone at 1-800-6310174.
Retiro De Equipo (Recall) de BD Vacutainer Urine Complete Kit
  • Tipo de evento
    Recall
  • ID del evento
    53650
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1026-2010
  • Fecha de inicio del evento
    2009-10-12
  • Fecha de publicación del evento
    2010-03-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-03-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86268
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Culture media, non-propagating transport - Product Code JTW
  • Causa
    A small amount of discoloration was noted on towelettes included in bd vacutainer urine collection kits. the entire kit components retain sterile interiors and no viable growth was detected on the towelettes.
  • Acción
    Recall notification letters were sent on 10/12/09 with return receipt requested. Customers were advised to contact your SO Sales Consultant for additional information, via e-mail at Vacutainer_TechServices@SD.com or via telephone at 1-800-6310174.
Retiro De Equipo (Recall) de Immulite 2000 Rubella Quantitative IgG, Immulite 2500 Rubella IgG
  • Tipo de evento
    Recall
  • ID del evento
    53675
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1033-2010
  • Fecha de inicio del evento
    2009-10-21
  • Fecha de publicación del evento
    2010-03-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-04-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86308
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Rubella IgG - Product Code LFX
  • Causa
    The recall was initiated because siemens healthcare diagnostics has identified there is the potential for patient results to be biased low (-0.3 sample to cutoff [s/co] ratio units) due to incompatibility of the toxoplasma igm kits with this particular lot of igg/igm sample diluent. all available lots of the immulite 2000/2500 toxoplasma igm kits (l2ktm/l5ktm) are incompatible with diluent lot 150.
  • Acción
    The customer notification was initiated on 10/22/2009 with the firm forwarding an Urgent Field Safety notice with attached Field Correction Effectiveness Check form to the affected consignees informing them of the issue and the products affected. The consignees were informed that Siemens is initiating the Field Correction (FC) to prevent IMMULITE 2000/2500 Toxoplasma IgM from being run with Diluent lot 150. The consignees were instructed in the interim, until replacement kit lots of RUB IgG and CMV IgG are received, your laboratory can continue using Rubella IgG, CMV IgG, or Toxoplasma IgM as long as Diluent Lot 150 is not loaded on the analyzer when running Toxoplasma IgM. Diluent Lot 150 can be used with RUB IgG and CMV IgG. Once the replacements lots are received, any unopened kit lots listed in the above table MUST BE RETURNED to Siemens per instructions that will accompany a separate Fed Ex Call Tag that will explain the proper return of the affected product. The consignees were also instructed to complete the attached Field Correction Effectiveness Check form and fax to the firm's technical solutions center. Additional questions should be directed to the firm at 973-927-2828.
Retiro De Equipo (Recall) de Immulite 2000 CMV IgG, and Immulite 2500 CMV IgG
  • Tipo de evento
    Recall
  • ID del evento
    53675
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1066-2010
  • Fecha de inicio del evento
    2009-10-21
  • Fecha de publicación del evento
    2010-03-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-04-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89379
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    CMV IgG - Product Code LFX
  • Causa
    The recall was initiated because siemens healthcare diagnostics has identified there is the potential for patient results to be biased low (-0.3 sample to cutoff [s/co] ratio units) due to incompatibility of the toxoplasma igm kits with this particular lot of igg/igm sample diluent. all available lots of the immulite 2000/2500 toxoplasma igm kits (l2ktm/l5ktm) are incompatible with diluent lot 150.
  • Acción
    The customer notification was initiated on 10/22/2009 with the firm forwarding an Urgent Field Safety notice with attached Field Correction Effectiveness Check form to the affected consignees informing them of the issue and the products affected. The consignees were informed that Siemens is initiating the Field Correction (FC) to prevent IMMULITE 2000/2500 Toxoplasma IgM from being run with Diluent lot 150. The consignees were instructed in the interim, until replacement kit lots of RUB IgG and CMV IgG are received, your laboratory can continue using Rubella IgG, CMV IgG, or Toxoplasma IgM as long as Diluent Lot 150 is not loaded on the analyzer when running Toxoplasma IgM. Diluent Lot 150 can be used with RUB IgG and CMV IgG. Once the replacements lots are received, any unopened kit lots listed in the above table MUST BE RETURNED to Siemens per instructions that will accompany a separate Fed Ex Call Tag that will explain the proper return of the affected product. The consignees were also instructed to complete the attached Field Correction Effectiveness Check form and fax to the firm's technical solutions center. Additional questions should be directed to the firm at 973-927-2828.
Retiro De Equipo (Recall) de BINDAZYME
  • Tipo de evento
    Recall
  • ID del evento
    55801
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1942-2010
  • Fecha de inicio del evento
    2009-10-28
  • Fecha de publicación del evento
    2010-06-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-06-30
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91848
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    in vitro diagnostic - Product Code DAK
  • Causa
    The recall was initiated after the binding site notified inova diagnostics, inc. that the affected bindazyme human c1q binding circulating immune complex eia kits may contain an elisa plate labeled as "tissue transglutaminase coated wells" instead of "c1q coated wells".
  • Acción
    Notification letters from INOVA Diagnostics Incorporated were mailed to each of the consignees via Certified mail on October 30, 2009. The notification letters inform the consignees of the reason for recall and provided instructions for final disposition of the recalled kits. In addition, a FAX back Attachment was attached to the recall notice for customers to respond to the recall.
Retiro De Equipo (Recall) de VITEK 2 Gram Negative Susceptibility Card, ASTGN26
  • Tipo de evento
    Recall
  • ID del evento
    56760
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0176-2011
  • Fecha de inicio del evento
    2010-09-16
  • Fecha de publicación del evento
    2010-11-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-05-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94675
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    System, test, automated, antimicrobial susceptibility, short incubation - Product Code LON
  • Causa
    Amended reason for recall: the piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for e. coli, as well as an additional 7 organisms; and the same drug is providing false resistant results for k. pneumoniae.
  • Acción
    bioMerieux issued a "Product Correction Notice" letter dated September 13, 2010, to their entire customer base (regardless of whether they ever ordered the recalled cards). The letters explained the reason for the recall and instructed the account to confirm all results for E. coli using a second method, and for K. pneumoniae, to confirm with a second method only for resistant results. These alternate test confirmations are to continue until further notice. The customers were to complete and return the enclosed Acknowledgement Form via fax at (314) 731-8689 or (919) 620-6350 which indicate that the notice has been read, the instructions provided in the "Actions Required" section were followed, and notes if they have received any reports of illness or injury related to this issue. All future shipments will include an orange multilanguage insert to go into the boxes reminding customers they must perform an alternate test for TZP/E. coli combinations and that customers must also perform an alternate method prior to reporting TZP results when a resistant result is obtained for the TZP/K. pneumoniae. Additionally, this recall letter will accompany shipments of instrument software kits for the new customers. The recalling firm issued a press release on 10/27/10 via the Associated Press notifying the public of the recall. The recalling firm expanded their recall to add 7 more organisms to the list of organism testing that were to be suppressed. As a result the recalling firm issued a letter dated 3/30/11 via Fed Ex on 4/4/11 flagged "URGENT PRODUCT CORRECTION NOTICE (EXPANDED RECALL), VITEK 2 Piperacillin/Tazobactam Test, Document #9300786." The letter describes the issues, how the issues impact the test results, describes the product changes that are going to take place, and provides instructions on required actions to be taken. The product changes will involve the eventual changeover to new cards that will be created which do not contain Piperacillin/Taz
Retiro De Equipo (Recall) de VITEK 2 Gram Negative Susceptibility Card, ASTGN27
  • Tipo de evento
    Recall
  • ID del evento
    56760
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0177-2011
  • Fecha de inicio del evento
    2010-09-16
  • Fecha de publicación del evento
    2010-11-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-05-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94676
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    System, test, automated, antimicrobial susceptibility, short incubation - Product Code LON
  • Causa
    Amended reason for recall: the piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for e. coli, as well as an additional 7 organisms; and the same drug is providing false resistant results for k. pneumoniae.
  • Acción
    bioMerieux issued a "Product Correction Notice" letter dated September 13, 2010, to their entire customer base (regardless of whether they ever ordered the recalled cards). The letters explained the reason for the recall and instructed the account to confirm all results for E. coli using a second method, and for K. pneumoniae, to confirm with a second method only for resistant results. These alternate test confirmations are to continue until further notice. The customers were to complete and return the enclosed Acknowledgement Form via fax at (314) 731-8689 or (919) 620-6350 which indicate that the notice has been read, the instructions provided in the "Actions Required" section were followed, and notes if they have received any reports of illness or injury related to this issue. All future shipments will include an orange multilanguage insert to go into the boxes reminding customers they must perform an alternate test for TZP/E. coli combinations and that customers must also perform an alternate method prior to reporting TZP results when a resistant result is obtained for the TZP/K. pneumoniae. Additionally, this recall letter will accompany shipments of instrument software kits for the new customers. The recalling firm issued a press release on 10/27/10 via the Associated Press notifying the public of the recall. The recalling firm expanded their recall to add 7 more organisms to the list of organism testing that were to be suppressed. As a result the recalling firm issued a letter dated 3/30/11 via Fed Ex on 4/4/11 flagged "URGENT PRODUCT CORRECTION NOTICE (EXPANDED RECALL), VITEK 2 Piperacillin/Tazobactam Test, Document #9300786." The letter describes the issues, how the issues impact the test results, describes the product changes that are going to take place, and provides instructions on required actions to be taken. The product changes will involve the eventual changeover to new cards that will be created which do not contain Piperacillin/Taz
Retiro De Equipo (Recall) de VITEK 2 Gram Negative Susceptibility Card, ASTGN28
  • Tipo de evento
    Recall
  • ID del evento
    56760
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0178-2011
  • Fecha de inicio del evento
    2010-09-16
  • Fecha de publicación del evento
    2010-11-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-05-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94686
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    System, test, automated, antimicrobial susceptibility, short incubation - Product Code LON
  • Causa
    Amended reason for recall: the piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for e. coli, as well as an additional 7 organisms; and the same drug is providing false resistant results for k. pneumoniae.
  • Acción
    bioMerieux issued a "Product Correction Notice" letter dated September 13, 2010, to their entire customer base (regardless of whether they ever ordered the recalled cards). The letters explained the reason for the recall and instructed the account to confirm all results for E. coli using a second method, and for K. pneumoniae, to confirm with a second method only for resistant results. These alternate test confirmations are to continue until further notice. The customers were to complete and return the enclosed Acknowledgement Form via fax at (314) 731-8689 or (919) 620-6350 which indicate that the notice has been read, the instructions provided in the "Actions Required" section were followed, and notes if they have received any reports of illness or injury related to this issue. All future shipments will include an orange multilanguage insert to go into the boxes reminding customers they must perform an alternate test for TZP/E. coli combinations and that customers must also perform an alternate method prior to reporting TZP results when a resistant result is obtained for the TZP/K. pneumoniae. Additionally, this recall letter will accompany shipments of instrument software kits for the new customers. The recalling firm issued a press release on 10/27/10 via the Associated Press notifying the public of the recall. The recalling firm expanded their recall to add 7 more organisms to the list of organism testing that were to be suppressed. As a result the recalling firm issued a letter dated 3/30/11 via Fed Ex on 4/4/11 flagged "URGENT PRODUCT CORRECTION NOTICE (EXPANDED RECALL), VITEK 2 Piperacillin/Tazobactam Test, Document #9300786." The letter describes the issues, how the issues impact the test results, describes the product changes that are going to take place, and provides instructions on required actions to be taken. The product changes will involve the eventual changeover to new cards that will be created which do not contain Piperacillin/Taz
Retiro De Equipo (Recall) de VITEK 2 Gram Negative Susceptibility Card, ASTGN29
  • Tipo de evento
    Recall
  • ID del evento
    56760
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0179-2011
  • Fecha de inicio del evento
    2010-09-16
  • Fecha de publicación del evento
    2010-11-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-05-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94687
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    System, test, automated, antimicrobial susceptibility, short incubation - Product Code LON
  • Causa
    Amended reason for recall: the piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for e. coli, as well as an additional 7 organisms; and the same drug is providing false resistant results for k. pneumoniae.
  • Acción
    bioMerieux issued a "Product Correction Notice" letter dated September 13, 2010, to their entire customer base (regardless of whether they ever ordered the recalled cards). The letters explained the reason for the recall and instructed the account to confirm all results for E. coli using a second method, and for K. pneumoniae, to confirm with a second method only for resistant results. These alternate test confirmations are to continue until further notice. The customers were to complete and return the enclosed Acknowledgement Form via fax at (314) 731-8689 or (919) 620-6350 which indicate that the notice has been read, the instructions provided in the "Actions Required" section were followed, and notes if they have received any reports of illness or injury related to this issue. All future shipments will include an orange multilanguage insert to go into the boxes reminding customers they must perform an alternate test for TZP/E. coli combinations and that customers must also perform an alternate method prior to reporting TZP results when a resistant result is obtained for the TZP/K. pneumoniae. Additionally, this recall letter will accompany shipments of instrument software kits for the new customers. The recalling firm issued a press release on 10/27/10 via the Associated Press notifying the public of the recall. The recalling firm expanded their recall to add 7 more organisms to the list of organism testing that were to be suppressed. As a result the recalling firm issued a letter dated 3/30/11 via Fed Ex on 4/4/11 flagged "URGENT PRODUCT CORRECTION NOTICE (EXPANDED RECALL), VITEK 2 Piperacillin/Tazobactam Test, Document #9300786." The letter describes the issues, how the issues impact the test results, describes the product changes that are going to take place, and provides instructions on required actions to be taken. The product changes will involve the eventual changeover to new cards that will be created which do not contain Piperacillin/Taz
Retiro De Equipo (Recall) de VITEK 2 Gram Negative Susceptibility Card, ASTGN30
  • Tipo de evento
    Recall
  • ID del evento
    56760
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0180-2011
  • Fecha de inicio del evento
    2010-09-16
  • Fecha de publicación del evento
    2010-11-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-05-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94688
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    System, test, automated, antimicrobial susceptibility, short incubation - Product Code LON
  • Causa
    Amended reason for recall: the piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for e. coli, as well as an additional 7 organisms; and the same drug is providing false resistant results for k. pneumoniae.
  • Acción
    bioMerieux issued a "Product Correction Notice" letter dated September 13, 2010, to their entire customer base (regardless of whether they ever ordered the recalled cards). The letters explained the reason for the recall and instructed the account to confirm all results for E. coli using a second method, and for K. pneumoniae, to confirm with a second method only for resistant results. These alternate test confirmations are to continue until further notice. The customers were to complete and return the enclosed Acknowledgement Form via fax at (314) 731-8689 or (919) 620-6350 which indicate that the notice has been read, the instructions provided in the "Actions Required" section were followed, and notes if they have received any reports of illness or injury related to this issue. All future shipments will include an orange multilanguage insert to go into the boxes reminding customers they must perform an alternate test for TZP/E. coli combinations and that customers must also perform an alternate method prior to reporting TZP results when a resistant result is obtained for the TZP/K. pneumoniae. Additionally, this recall letter will accompany shipments of instrument software kits for the new customers. The recalling firm issued a press release on 10/27/10 via the Associated Press notifying the public of the recall. The recalling firm expanded their recall to add 7 more organisms to the list of organism testing that were to be suppressed. As a result the recalling firm issued a letter dated 3/30/11 via Fed Ex on 4/4/11 flagged "URGENT PRODUCT CORRECTION NOTICE (EXPANDED RECALL), VITEK 2 Piperacillin/Tazobactam Test, Document #9300786." The letter describes the issues, how the issues impact the test results, describes the product changes that are going to take place, and provides instructions on required actions to be taken. The product changes will involve the eventual changeover to new cards that will be created which do not contain Piperacillin/Taz
Retiro De Equipo (Recall) de VITEK 2 Gram Negative Susceptibility Card, ASTGN39
  • Tipo de evento
    Recall
  • ID del evento
    56760
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0188-2011
  • Fecha de inicio del evento
    2010-09-16
  • Fecha de publicación del evento
    2010-11-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-05-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94697
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    System, test, automated, antimicrobial susceptibility, short incubation - Product Code LON
  • Causa
    Amended reason for recall: the piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for e. coli, as well as an additional 7 organisms; and the same drug is providing false resistant results for k. pneumoniae.
  • Acción
    bioMerieux issued a "Product Correction Notice" letter dated September 13, 2010, to their entire customer base (regardless of whether they ever ordered the recalled cards). The letters explained the reason for the recall and instructed the account to confirm all results for E. coli using a second method, and for K. pneumoniae, to confirm with a second method only for resistant results. These alternate test confirmations are to continue until further notice. The customers were to complete and return the enclosed Acknowledgement Form via fax at (314) 731-8689 or (919) 620-6350 which indicate that the notice has been read, the instructions provided in the "Actions Required" section were followed, and notes if they have received any reports of illness or injury related to this issue. All future shipments will include an orange multilanguage insert to go into the boxes reminding customers they must perform an alternate test for TZP/E. coli combinations and that customers must also perform an alternate method prior to reporting TZP results when a resistant result is obtained for the TZP/K. pneumoniae. Additionally, this recall letter will accompany shipments of instrument software kits for the new customers. The recalling firm issued a press release on 10/27/10 via the Associated Press notifying the public of the recall. The recalling firm expanded their recall to add 7 more organisms to the list of organism testing that were to be suppressed. As a result the recalling firm issued a letter dated 3/30/11 via Fed Ex on 4/4/11 flagged "URGENT PRODUCT CORRECTION NOTICE (EXPANDED RECALL), VITEK 2 Piperacillin/Tazobactam Test, Document #9300786." The letter describes the issues, how the issues impact the test results, describes the product changes that are going to take place, and provides instructions on required actions to be taken. The product changes will involve the eventual changeover to new cards that will be created which do not contain Piperacillin/Taz
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