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  • Dispositivo 2589
  • Fabricante 31827
  • Evento 2705
  • Implante 0
Retiro De Equipo (Recall) de iSTAT EC4 Cartridge
  • Tipo de evento
    Recall
  • ID del evento
    44972
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0372-2008
  • Fecha de inicio del evento
    2007-10-18
  • Fecha de publicación del evento
    2007-12-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-07-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=64692
  • 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
    Ion Specific Electrode (Sodium) - Product Code JGS
  • Causa
    Difficult to close -- certain lots of i-stat cartridges are difficult to close, will not close or do not stay closed.
  • Acción
    Abbott Point of Care sent and Urgent Notice to all i-STAT Customers (US and Canadian consignees) notifying them that certain lots of i-STAT cartridges have snap closures that are difficult to close, will not close or do not stay closed. The customers were asked to review the lot numbers on the enclosure and, if the facility has any cartridges from the lot numbers listed, they should remove from service immediately.
Retiro De Equipo (Recall) de iSTAT E3 Cartridge
  • Tipo de evento
    Recall
  • ID del evento
    44972
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0371-2008
  • Fecha de inicio del evento
    2007-10-18
  • Fecha de publicación del evento
    2007-12-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-07-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=64691
  • 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
    Ion Specific Electrode (Sodium) - Product Code JGS
  • Causa
    Difficult to close -- certain lots of i-stat cartridges are difficult to close, will not close or do not stay closed.
  • Acción
    Abbott Point of Care sent and Urgent Notice to all i-STAT Customers (US and Canadian consignees) notifying them that certain lots of i-STAT cartridges have snap closures that are difficult to close, will not close or do not stay closed. The customers were asked to review the lot numbers on the enclosure and, if the facility has any cartridges from the lot numbers listed, they should remove from service immediately.
Retiro De Equipo (Recall) de iSTAT 6 Cartridge
  • Tipo de evento
    Recall
  • ID del evento
    44972
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0370-2008
  • Fecha de inicio del evento
    2007-10-18
  • Fecha de publicación del evento
    2007-12-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-07-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=64690
  • 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
    Ion Specific Electrode (Sodium) - Product Code JGS
  • Causa
    Difficult to close -- certian lots of i-stat cartridges are difficult to close, will not close or do not stay closed.
  • Acción
    Abbott Point of Care sent and Urgent Notice to all i-STAT Customers (US and Canadian consignees) notifying them that certain lots of i-STAT cartridges have snap closures that are difficult to close, will not close or do not stay closed. The customers were asked to review the lot numbers on the enclosure and, if the facility has any cartridges from the lot numbers listed, they should remove from service immediately.
Retiro De Equipo (Recall) de ARCHITECT cSystem
  • Tipo de evento
    Recall
  • ID del evento
    44961
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0147-2008
  • Fecha de inicio del evento
    2007-09-05
  • Fecha de publicación del evento
    2007-11-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-10-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=64657
  • 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
    Processing Module, for In Vitro Diagnostics - Product Code JJE
  • Causa
    Incorrect sample/test identification: due to a software timing defect with certain versions of architect csystem software, test results may be incorrectly associated to a sample identification during specific sample-processing conditions of the robotic sample handler.
  • Acción
    Notification letters sent to consignees on 09/17/07. Consignees informed of the software defect and the conditions that would cause the software error to occur. Consignees told they would be contacted by an Abbott Field Service Rep who would install ARCHITECT System Software v3.11 and were asked to respond via fax using Customer Reply form acknowledging receipt and understanding of correction letter. Firm recalling to hospital/user level.
Retiro De Equipo (Recall) de ARCHITECT cSystem
  • Tipo de evento
    Recall
  • ID del evento
    44961
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0146-2008
  • Fecha de inicio del evento
    2007-09-05
  • Fecha de publicación del evento
    2007-11-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-10-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=64656
  • 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
    Processing Module, for In Vitro Diagnostics; - Product Code JJE
  • Causa
    Incorrect sample/test identification: due to a software timing defect with certain versions of architect csystem software, test results may be incorrectly associated to a sample identification during specific sample-processing conditions of the robotic sample handler.
  • Acción
    Notification letters sent to consignees on 09/17/07. Consignees informed of the software defect and the conditions that would cause the software error to occur. Consignees told they would be contacted by an Abbott Field Service Rep who would install ARCHITECT System Software v3.11 and were asked to respond via fax using Customer Reply form acknowledging receipt and understanding of correction letter. Firm recalling to hospital/user level.
Retiro De Equipo (Recall) de Nova Biomedical
  • Tipo de evento
    Recall
  • ID del evento
    44941
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0295-2008
  • Fecha de inicio del evento
    2007-09-17
  • Fecha de publicación del evento
    2008-01-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-03-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=64558
  • 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
    Sodium Test System calibrator - Product Code JBS
  • Causa
    Elevated normalized ionized calcium (nca) and normalized ionized magnesium (nmg) calculated values on patient samples.
  • Acción
    Nova issued a Customer Advisory Notice notification by phone on 9/17/07 to contact customers using a script . If the facility reports Normalized Ionized Calcium or Normalized Ionized Magnesium, Nova Biomedical will replace existing stock of Nova 8 calibrator packs. If the facility does not report Normalized Ionized Calcium or Normalized Ionized Magnesium, the account can continue to use the existing lot of calibrator packs.This contact will be documented within the Nova Biomedical complaint database. Intemational Customer Advisory Notice being sent to Nova Biomedical Subsidiariies and Distributors by Federal Express Envelope.The Federal Express envelopes tracking number will be used for delivery confirmation.
Retiro De Equipo (Recall) de AmniSure
  • Tipo de evento
    Recall
  • ID del evento
    44937
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0120-2008
  • Fecha de inicio del evento
    2007-10-03
  • Fecha de publicación del evento
    2008-01-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-02-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=64550
  • 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
    Fetal Membrane Rupture Test - Product Code JJX
  • Causa
    Weak true postive/false negative results: weak true positive or false negatives in ruptured fetal membranes may occur due to a "hook effect".
  • Acción
    AmniSure notified users by Medical Device Correction (Recall) letter dated October 1, 2007 issued via US Mail. The letter provides additional labeling instructions and a checklist for trouble shooting, including a diluation procedure that allows users to determine and solve the problem of the hook effect with this device.
Retiro De Equipo (Recall) de ESA LeadCare
  • Tipo de evento
    Recall
  • ID del evento
    44909
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0043-2008
  • Fecha de inicio del evento
    2007-09-20
  • Fecha de publicación del evento
    2007-10-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-03-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=64512
  • 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
    lead test in vitro diagnostic - Product Code DOF
  • Causa
    Level 1 and level 2 control values were incorrectly assigned.
  • Acción
    ESA notifed Distributors and End Users by telephone and letter on 9/20/07. Distributors and End Users will be informed of the Level 1 and 2 Control value assignment change. End Users will be sent a new Level 1 and 2 Control Vial label for each vial they originally received. Distributors will be asked to return all test kits in their inventory to ESA Biosciences.
Retiro De Equipo (Recall) de ESA LeadCare
  • Tipo de evento
    Recall
  • ID del evento
    44909
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0042-2008
  • Fecha de inicio del evento
    2007-09-20
  • Fecha de publicación del evento
    2007-10-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-03-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=64511
  • 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
    lead test in vitro diagnostic - Product Code DOF
  • Causa
    Level 1 and level 2 control values were incorrectly assigned.
  • Acción
    ESA notifed Distributors and End Users by telephone and letter on 9/20/07. Distributors and End Users will be informed of the Level 1 and 2 Control value assignment change. End Users will be sent a new Level 1 and 2 Control Vial label for each vial they originally received. Distributors will be asked to return all test kits in their inventory to ESA Biosciences.
Retiro De Equipo (Recall) de Mega Diagnostics Alcohol Standard
  • Tipo de evento
    Recall
  • ID del evento
    37254
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0744-2007
  • Fecha de inicio del evento
    2006-09-20
  • Fecha de publicación del evento
    2007-04-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-06-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50205
  • 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
    Alcohol Standard - Product Code JIX
  • Causa
    Potential for microorganism growth in the alcohol standard.
  • Acción
    The firm sent a recall notification to their customer in Indonesia and advised them to dispose of the product
Retiro De Equipo (Recall) de Mega Diagnostics Ammonia/Alcohol Controls
  • Tipo de evento
    Recall
  • ID del evento
    37254
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0743-2007
  • Fecha de inicio del evento
    2006-09-20
  • Fecha de publicación del evento
    2007-04-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-06-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50199
  • 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
    Ammonia/Alcohol Controls - Product Code JIX
  • Causa
    Potential for microorganism growth in the alcohol standard and or unexpected qc changes in the ammonia portion of the ammonia/alcohol control product.
  • Acción
    The firm sent a recall notification to their customer in Indonesia and advised them to dispose of the product
Retiro De Equipo (Recall) de ADVIA 2400 Chemistry System
  • Tipo de evento
    Recall
  • ID del evento
    36713
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0353-2007
  • Fecha de inicio del evento
    2006-09-08
  • Fecha de publicación del evento
    2007-01-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-05-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49709
  • 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 LEG
  • Causa
    Bayer received a customer complaint where the valproic acid quality control material recovered lower than target when it was run in a panel of other therapeutic drug (tdm) assays. the under recovery observed by the customer was approximately -25%. investigation into this issue was initiated promptly following receipt of this complaint.
  • Acción
    On 9/08/06, a Support Bulletin was sent to all affected Bayer HealthCare LLC Branches in order to inform them of the issue and to provide them with instructions for the 'field correction'. On 9/08/06, a Customer Bulletin was sent to all affected Bayer HealthCare LLC Branches both in the US and worldwide for communication with the affected end user customers. The bulletin advises of the problem and the corrective action. A Completion Confirmation (Fax-back) Form was included to ensure that all customers worldwide have been notified and have complied with the mandatory action. The Customer Bulletin is to be sent to all affected end user customers. Bayer Technical Service Specialists will follow-up with all of the ADVIA Chemistry System customers to make sure they have understood the bulletin and to ask that they return the FAX-back Completion Confirmation Form to Bayer HealthCare. If Bayer HealthCare does not receive the form in a timely manner, specialists in the Bayer Technical Care Center will contact the customer through whatever means possible in an effort to obtain 100% effectiveness on this communication.
Retiro De Equipo (Recall) de ADVIA 1650 Chemistry System
  • Tipo de evento
    Recall
  • ID del evento
    36713
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0352-2007
  • Fecha de inicio del evento
    2006-09-08
  • Fecha de publicación del evento
    2007-01-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-05-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49708
  • 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 LEG
  • Causa
    Bayer received a customer complaint where the valproic acid quality control material recovered lower than target when it was run in a panel of other therapeutic drug (tdm) assays. the under recovery observed by the customer was approximately -25%. investigation into this issue was initiated promptly following receipt of this complaint.
  • Acción
    On 9/08/06, a Support Bulletin was sent to all affected Bayer HealthCare LLC Branches in order to inform them of the issue and to provide them with instructions for the 'field correction'. On 9/08/06, a Customer Bulletin was sent to all affected Bayer HealthCare LLC Branches both in the US and worldwide for communication with the affected end user customers. The bulletin advises of the problem and the corrective action. A Completion Confirmation (Fax-back) Form was included to ensure that all customers worldwide have been notified and have complied with the mandatory action. The Customer Bulletin is to be sent to all affected end user customers. Bayer Technical Service Specialists will follow-up with all of the ADVIA Chemistry System customers to make sure they have understood the bulletin and to ask that they return the FAX-back Completion Confirmation Form to Bayer HealthCare. If Bayer HealthCare does not receive the form in a timely manner, specialists in the Bayer Technical Care Center will contact the customer through whatever means possible in an effort to obtain 100% effectiveness on this communication.
Retiro De Equipo (Recall) de ADVIA 1200 Chemistry System
  • Tipo de evento
    Recall
  • ID del evento
    36713
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0351-2007
  • Fecha de inicio del evento
    2006-09-08
  • Fecha de publicación del evento
    2007-01-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-05-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49707
  • 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 LEG
  • Causa
    Bayer received a customer complaint where the valproic acid quality control material recovered lower than target when it was run in a panel of other therapeutic drug (tdm) assays. the under recovery observed by the customer was approximately -25%.
  • Acción
    On 9/08/06, a Support Bulletin was sent to all affected Bayer HealthCare LLC Branches in order to inform them of the issue and to provide them with instructions for the 'field correction'. On 9/08/06, a Customer Bulletin was sent to all affected Bayer HealthCare LLC Branches both in the US and worldwide for communication with the affected end user customers. The bulletin advises of the problem and the corrective action. A Completion Confirmation (Fax-back) Form was included to ensure that all customers worldwide have been notified and have complied with the mandatory action. The Customer Bulletin is to be sent to all affected end user customers. Bayer Technical Service Specialists will follow-up with all of the ADVIA Chemistry System customers to make sure they have understood the bulletin and to ask that they return the FAX-back Completion Confirmation Form to Bayer HealthCare. If Bayer HealthCare does not receive the form in a timely manner, specialists in the Bayer Technical Care Center will contact the customer through whatever means possible in an effort to obtain 100% effectiveness on this communication.
Retiro De Equipo (Recall) de Life Scan One Touch Ultra
  • Tipo de evento
    Recall
  • ID del evento
    36932
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0477-2007
  • Fecha de inicio del evento
    2006-10-09
  • Fecha de publicación del evento
    2007-02-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-01-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49586
  • 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
    Blood Glucose Test Strips - Product Code NBW
  • Causa
    Counterfeit test strips (manufacturer unknown).
  • Acción
    Matrix Distributors contacted by telephone those pharmacies to which they had shipped the affected lots. These call were conducted from 10/9 to 10/13/2006. A follow-up letter was issued to the pharmacies extending the recall to the user level.
Retiro De Equipo (Recall) de One Touch
  • Tipo de evento
    Recall
  • ID del evento
    36863
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0266-2007
  • Fecha de inicio del evento
    2006-10-14
  • Fecha de publicación del evento
    2007-01-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2007-06-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49472
  • 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
    Blood Glucose Test Strips - Product Code NBW
  • Causa
    Counterfeit product (manufacturer unknown).
  • Acción
    The firm identified the customers who had been sent OneTouch test strips since August 2006 and contacted each by phone to identify the lot number of the test strips in the customer's possession. A letter was sent on 11/21/2006 by first class mail which identified the lot numbers identified in the letter from the law firm and providing instructions to follow if the affected lots were found.
Retiro De Equipo (Recall) de Diagnostic Chemicals Limited
  • Tipo de evento
    Recall
  • ID del evento
    36864
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0536-2007
  • Fecha de inicio del evento
    2006-09-06
  • Fecha de publicación del evento
    2007-02-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2007-05-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49471
  • 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 JIX
  • Causa
    Microalbumin multi calibrator mislabeled label on level 5 and level 6, cap label correct.
  • Acción
    Diagnostic Chemicals Ltd, Canada notified customers by telephone and fax on 9/06/06 and advised to use the cap label to determine concentration of the calibrators. Accounts were asked to confirm and acknowledge receipt of the letter.
Retiro De Equipo (Recall) de One Touch Ultra test strips
  • Tipo de evento
    Recall
  • ID del evento
    36690
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0206-2007
  • Fecha de inicio del evento
    2006-10-19
  • Fecha de publicación del evento
    2007-01-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2009-12-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49174
  • 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
    Blood Glucose Test strips - Product Code NBW
  • Causa
    Counterfeit-blood glucose test strips (manufacturer unknown).
  • Acción
    The recalling firm notified its consignees of the problem and the recall by telephone on 10/19/2006. The firm followed this with a written notice on 10/30/2006.
Retiro De Equipo (Recall) de One Touch
  • Tipo de evento
    Recall
  • ID del evento
    36663
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0263-2007
  • Fecha de inicio del evento
    2006-10-10
  • Fecha de publicación del evento
    2006-12-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-05-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49114
  • 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
    Blood Glucose Test Strips - Product Code CGA
  • Causa
    Counterfeit (manufacturer unknown).
  • Acción
    Firm started contacting pharmacists beginning 10/10/06. The phone call told the pharmacist that certain lots were identified by LifeScan as counterfeit and not to further distribute. Recontact on 10/27/2006 updated instructions to pharmacists to recall to the ''user/consumer'' level.
Retiro De Equipo (Recall) de One Touch Ultra
  • Tipo de evento
    Recall
  • ID del evento
    36656
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0262-2007
  • Fecha de inicio del evento
    2006-10-13
  • Fecha de publicación del evento
    2006-12-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2007-07-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49106
  • 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
    Blood Glucose Test Strips - Product Code CGA
  • Causa
    Counterfeit glucose test strips (manufacturer unknown).
  • Acción
    Medical Plastic Devices, Quebec, Canada notiifed customers by telephone on 10/17/06 and completed notification by letter on 10/18/06.
Retiro De Equipo (Recall) de One Touch Basic/Profile
  • Tipo de evento
    Recall
  • ID del evento
    36656
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0261-2007
  • Fecha de inicio del evento
    2006-10-13
  • Fecha de publicación del evento
    2006-12-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2007-07-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49105
  • 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
    Blood Glucose Test Strips - Product Code NBW
  • Causa
    Counterfeit glucose test strips (manufacturer unknown).
  • Acción
    Medical Plastic Devices, Quebec, Canada notiifed customers by telephone on 10/17/06 and completed notification by letter on 10/18/06.
Retiro De Equipo (Recall) de ONE TOUCH
  • Tipo de evento
    Recall
  • ID del evento
    36622
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0207-2007
  • Fecha de inicio del evento
    2006-10-17
  • Fecha de publicación del evento
    2006-12-08
  • 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=49018
  • 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
    Blood Glucose Test Strips - Product Code NBW
  • Causa
    Counterfeit-(manufacturer unknown).
  • Acción
    The recalling firm faxed, e-mailed and/or mailed ''Urgent Medical Device'' letters and response forms (dated 10/17/06) to the 5 distributor accounts.
Retiro De Equipo (Recall) de Vacutainer
  • Tipo de evento
    Recall
  • ID del evento
    36585
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0253-2007
  • Fecha de inicio del evento
    2006-09-08
  • Fecha de publicación del evento
    2006-12-06
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2007-05-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48949
  • 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
    Luer-Lok Access Device - Product Code JKA
  • Causa
    Reports of failure of the luer lok access device to lock securely to certain catheter devices because the male luer taper surface is not within the specification.
  • Acción
    Recall notification was sent 9/8/06 to all direct accounts and distributors by US mail, return receipt requested. Consignees were asked to send product back to BD with the packing slip and shipping labels enclosed
Retiro De Equipo (Recall) de VITROS Chemistry Products LIPA Slides GEN 48 Coating 3235
  • Tipo de evento
    Recall
  • ID del evento
    36512
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0245-2007
  • Fecha de inicio del evento
    2006-10-09
  • Fecha de publicación del evento
    2006-12-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-05-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48782
  • 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
    LIPA in vitro diagnostic - Product Code CHI
  • Causa
    The firm identified circumstances in which biased results or calibration failures can be observed when using any lot of vitros¿ lipa slides if they have been stored on the vitros¿ chemistry systems for more than 2 days.
  • Acción
    On 10/09/06, Ortho-Clinical Diagnostics sent "IMPORTANT DISTRIBUTOR NOTIFICATION" Letters and "Confirmation of Receipt" Forms via Federal Express to all distributor accounts informing them of the "field correction", and instructing them to inform their customers who received these slides of this issue. OCD foreign affiliates were informed of this action by e-mail on 10/09/06, and instructed them to inform their customers who received the LIPA slides of this "field correction". OCD also sent "IMPORTANT PRODUCT CORRECTION NOTIFICATION" Letters and "Confirmation of Receipt" Forms to US end-user consignees that received the LIPA slides directly from OCD via US Postal Service, informing them of this "field correction" and that they may continue to use their current lot of Coating 3235 LIPA Slides until replacement product arrived providing that they followed the instructions in the letter.
Retiro De Equipo (Recall) de Tosoh Folate calibrator sets
  • Tipo de evento
    Recall
  • ID del evento
    36506
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0082-2007
  • Fecha de inicio del evento
    2006-09-01
  • Fecha de publicación del evento
    2006-10-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2007-07-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48775
  • 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
    Folate calibrator sets - Product Code JIS
  • Causa
    Reports of low calibration rate value flags; use of the recalled product may result in failure to calibrate the instrument.
  • Acción
    The firm mailed Urgent: Medical Device Recall letters to their customer accounts on 9/5/2006. The letter informs the customers of the calibration problem and asks that the customers examine their inventories for the presence of the suspect product and place any product found in quarantine. The letter also asks that the customers identify their subaccount/customers and notify them of the recall with a copy of the recall letter, if the product has been further distributed. The recall letter is accompanied by a Response form which the customer is asked to complete and return to TOSOH as soon as possible. The Response form requires reporting of infomation concerning the amount and disposition of all product on-hand. It also includes a section for use by the distributor/customers for indicating whether or not their customers have been notified as well as the names and addressed of the distributor''s subaccounts. Should the customer(s) have any questions, the recall letter provides a telephone number and the name of a contact person to whom questions can be addressed.
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Los dispositivos médicos ayudan con el diagnóstico, la prevención y el tratamiento de muchas lesiones y enfermedades. A través de la International Medical Devices Database no estamos sugiriendo que compañías u otras entidades mencionadas en la base de datos hayan sido parte de una conducta ilegal o hayan actuado de manera impropia. Un mismo dispositivo médico puede tener distintos nombres en diferentes países. Esta base de datos no busca proporcionar asesoría médica. Los pacientes deben consultar con sus médicos para determinar si la data contiene información relevante y si la misma tiene implicaciones médicas para ellos.

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