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  • Dispositivo 2589
  • Fabricante 31827
  • Evento 2705
  • Implante 0
Retiro De Equipo (Recall) de Statspin Express 4 centrifuge
  • Tipo de evento
    Recall
  • ID del evento
    2010-0193
  • Fecha
    2010-03-05
  • País del evento
    Finland
  • Fuente del evento
    VNSAWH
  • Notas / Alertas
    Finnish data is current through April 2018. All of the data comes from Valvira - National Supervisory Authority for Welfare and Health, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Finland.
  • Notas adicionales en la data
    Source: M2
  • Causa
    Device failure / feature before use - design.
Retiro De Equipo (Recall) de UniCel® DxC 600, UniCel® DxC 600 PRO, UniCel® DxC 600i, UniCel® DxC ...
  • Tipo de evento
    Recall
  • ID del evento
    2010-0419
  • Fecha
    2010-05-04
  • País del evento
    Finland
  • Fuente del evento
    VNSAWH
  • Notas / Alertas
    Finnish data is current through April 2018. All of the data comes from Valvira - National Supervisory Authority for Welfare and Health, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Finland.
  • Notas adicionales en la data
    Source: NCAR
  • Causa
    Device failure / feature before use - packing - operating instructions.
Retiro De Equipo (Recall) de GEM Premier 4000 cartridge labelled with potassium
  • Tipo de evento
    Recall
  • ID del evento
    2011-0439
  • Fecha
    2011-06-10
  • País del evento
    Finland
  • Fuente del evento
    VNSAWH
  • Notas / Alertas
    Finnish data is current through April 2018. All of the data comes from Valvira - National Supervisory Authority for Welfare and Health, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Finland.
  • Notas adicionales en la data
    Source: FSCA
  • Causa
    Device failure / feature before use - material / component.
Retiro De Equipo (Recall) de GEM PREMIER 4000 CARTRIDGE K+ REPORTING
  • Tipo de evento
    Recall
  • ID del evento
    2011-0653
  • Fecha
    2011-09-16
  • País del evento
    Finland
  • Fuente del evento
    VNSAWH
  • Notas / Alertas
    Finnish data is current through April 2018. All of the data comes from Valvira - National Supervisory Authority for Welfare and Health, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Finland.
  • Notas adicionales en la data
    Source: NCAR
Retiro De Equipo (Recall) de OneTouch Verio IQ
  • Tipo de evento
    Recall
  • ID del evento
    2013-0486
  • Fecha
    2013-03-22
  • País del evento
    Finland
  • Fuente del evento
    VNSAWH
  • Notas / Alertas
    Finnish data is current through April 2018. All of the data comes from Valvira - National Supervisory Authority for Welfare and Health, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Finland.
  • Notas adicionales en la data
    Source: NCAR
  • Causa
    Device failure / feature before use - software.
Retiro De Equipo (Recall) de FreeStyle Blood Glucose Test Strips, FreeStyle Lite Blood Glucose Te...
  • Tipo de evento
    Recall
  • ID del evento
    2013-2189
  • Fecha
    2014-01-17
  • País del evento
    Finland
  • Fuente del evento
    VNSAWH
  • Notas / Alertas
    Finnish data is current through April 2018. All of the data comes from Valvira - National Supervisory Authority for Welfare and Health, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Finland.
  • Notas adicionales en la data
    Source: M2
  • Causa
    Device failure / feature before use - manufacturing.
Retiro De Equipo (Recall) de Blood Glucose Test Strips (see attachment A)
  • Tipo de evento
    Recall
  • ID del evento
    2013-2106
  • Fecha
    2013-12-11
  • País del evento
    Finland
  • Fuente del evento
    VNSAWH
  • Notas / Alertas
    Finnish data is current through April 2018. All of the data comes from Valvira - National Supervisory Authority for Welfare and Health, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Finland.
  • Notas adicionales en la data
    Source: FSCA
  • Causa
    Device failure / feature before use - manufacturing.
Retiro De Equipo (Recall) de SPOTCHEMII glucose, SPOTCHEM II PANEL-1, SPOTCHEM II PANEL-V, SPOTCH...
  • Tipo de evento
    Recall
  • ID del evento
    2016-0200
  • Fecha
    2016-02-02
  • País del evento
    Finland
  • Fuente del evento
    VNSAWH
  • Notas / Alertas
    Finnish data is current through April 2018. All of the data comes from Valvira - National Supervisory Authority for Welfare and Health, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Finland.
  • Notas adicionales en la data
    Source: FSCA
  • Causa
    Device failure / feature before use - material / component.
Retiro De Equipo (Recall) de Device Recall SoftPath
  • Tipo de evento
    Recall
  • ID del evento
    69837
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1065-2015
  • Fecha de inicio del evento
    2014-11-26
  • Fecha de publicación del evento
    2015-02-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-05-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131609
  • 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
    Laboratory Information System - Product Code JQP
  • Causa
    Modifications to diagnostic text may be: 1) saved to the database but not appear on the report sent to the physician; or 2) documented on the report, but not saved to the database.
  • Acción
    On 11/26/2014 SCC Soft Computer sent a Correction Communication to their consignees: Corrective Action: Versions 4.3.0.8 through 4.4.0.2 will have a mandatory hotfix created. Due to the amount of versions affected, the range of availability dates will be 11/24/2014 through 12/30/2014. Utility: A utility will be made available to be run on your Live system that will identify cases in which there is a disparity between the diagnosis text in the document and the database. The utility output will be provided for client review and validation.
Retiro De Equipo (Recall) de Device Recall UniStrip1
  • Tipo de evento
    Recall
  • ID del evento
    69856
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0855-2015
  • Fecha de inicio del evento
    2014-11-20
  • Fecha de publicación del evento
    2014-12-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-05-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131711
  • 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, blood glucose, over the counter - Product Code NBW
  • Causa
    Failure to submit a 510(k) for device labeling changes.
  • Acción
    UniStrip Technologies sent an Urgent Device Recall letter dated November 20, 2014, to all affected customers. They were instructed to immediately inform any of their retail accounts of the recall and have them return any of the recalled product to the distributor. The product is then to be returned to Unistrip Technologies. A reply form was included to be completed by the retail accounts and returned to the distributor who would in turn return the form to Unistrip Technologies to track returns. If you have any further questions, please call 1-866-861-8066.
Retiro De Equipo (Recall) de Device Recall DrugCheck Drugs of Abuse Ketamine Dip Test
  • Tipo de evento
    Recall
  • ID del evento
    70008
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1033-2015
  • Fecha de inicio del evento
    2014-11-21
  • Fecha de publicación del evento
    2015-01-30
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132104
  • 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
    Test system, for drugs of abuse - Product Code MGX
  • Causa
    This recall has been initiated due to potential false positives results when using the test to screen for ketamine. use of this product may give incorrect screening results.
  • Acción
    Consignees were sent an Express Diagnostic Int. Inc., "Urgent" Letter dated 11//21/2014. The letter described the problem and the product involved in the recall. It advised consignees to quarantine the product. If the product has been further distributed, consignees were advised to notify their customers at once, Consignees were requested to complete and return the "Acknowledgement Form" either via fax to 1-507-526-2252 or e-mail Quality@drugcheck.com. For questions consignees can contact Jackie Gale, Director of Quality Systems and Regulatory Affairs at 1-507-526-3951.
Retiro De Equipo (Recall) de Device Recall The Roche OMNI S Analyzer: cobas b 221, versions 5 and 6
  • Tipo de evento
    Recall
  • ID del evento
    70023
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1041-2015
  • Fecha de inicio del evento
    2014-12-18
  • Fecha de publicación del evento
    2015-02-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-02-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132123
  • 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
    Glucose oxidase, glucose - Product Code CGA
  • Causa
    Chemical component of the f3 fluid pack and environmental bacterial contamination causes a positive bias up to 39% at 4.1 mmol/l for the glucose measurement and 30% at 4.12 mmol/l for lactate. urea readings are unaffected.
  • Acción
    Roche Diagnostics has confirmed an issue with the calibration and QC stability of MSS parameters for cobas b 221 <6> systems. Internal investigations identified the formation of white deposits in the fluidic system, especially in the SD cartridge tubing, as the cause for the premature failure of the MSS parameters. These white deposits can potentially affect the fluidic pathways of both the Standby solution and the calibration solutions Cal1 to Cal4 (from the S3 Fluid Pack) and may reduce the lifetime of metabolite sensor cartridges. The cause of the white deposit has been identified as a chemical component of the S3 Fluid Pack solutions, as well as environmental bacterial contamination. Since this issue involves the S3 Fluid Pack, only the cobas b 221 <6> system is impacted. This issue may have an effect on the calibration of Glucose and Lactate parameters, which may lead to patient results being affected, as calibration drifts may not be detected by calibration and QC procedures. Glucose and Lactate are the only parameters affected by this issue. As a result, Roche is implementing an interim corrective action to be performed on your systems on a regular basis by Roche Field Engineering Specialist (FESs). Read the Urgent Medical Device Correction (UMDC) in its entirety. " Continue to run and maintain your cobas b 221 <6> system as per the Instructions for Use. " Complete the attached fax form and fax it to 1-888-656-6385. " File this UMDC for future reference. Please contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-526-2272 if you have questions about the information contained in this UMDC. Public Contact is Todd Siesky, at todd.siesky@roche.com.
Retiro De Equipo (Recall) de Device Recall SoftLab with SA HIS versions 4.0.7.04.0.7.1
  • Tipo de evento
    Recall
  • ID del evento
    70021
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1038-2015
  • Fecha de inicio del evento
    2014-05-20
  • Fecha de publicación del evento
    2015-02-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-05-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132127
  • 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
    Calculator/data processing module, for clinical use - Product Code JQP
  • Causa
    The interface fails to send abnormal flags for reference lab test results.
  • Acción
    The firm sent out 2 CORRECTION COMMUNICATIONS informing consignees of functionality in release of 4.0.7 HIS Add-on interfaces which SCC has designated to be a potential patient Risk-to-Health issue. Further the corrective action indicated HIS releases 4.0.7.2 and higher will be corrected. Hot Fixes have been developed for HIS Add-on patches 4.0.7.0 and 4.0.7.1. Lastly the communication requests that the user "please acknowledge receipt of this task and grant permission to load the mandatory hot fix(es). Thank you."
Retiro De Equipo (Recall) de Device Recall Architect c8000
  • Tipo de evento
    Recall
  • ID del evento
    71473
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2202-2015
  • Fecha de inicio del evento
    2015-06-11
  • Fecha de publicación del evento
    2015-07-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-02-09
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137918
  • 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
    Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
  • Causa
    The architect c8000 instrument contains tubing that does not meet specifications and has the potential to leak.
  • Acción
    Abbott notified thier affected consignees via phone or visit on 5/29/15. A follow up Product Recall notification letter dated June 4, 2015 was sent to affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to immediately discontinue use of the product, Abbott representative will be make all necessary arrangements for replacing your impacted instruments(s), follow your laboratory protocol regarding the need to review previously reported patient results and retain this notification for laboratory records. For questions contact Customer Service at 1-877-4ABBOTT.
Retiro De Equipo (Recall) de Device Recall VITROS 3600 Immunodiagnostic System
  • Tipo de evento
    Recall
  • ID del evento
    69830
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0967-2015
  • Fecha de inicio del evento
    2014-11-19
  • Fecha de publicación del evento
    2015-01-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-05-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131869
  • 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
    Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
  • Causa
    Software anomaly: the firm has identified an anomaly with vitros system software version 3.1 and below, and determined that the software may not properly identify an expired calibration.
  • Acción
    On 11/19/2014, IMPORTANT PRODUCT CORRECTION NOTIFICATION letter (Ref. CL2014-296, dated 11/19/2014) was sent via FedEx overnight courier or ORTHO PLUS e-Communications and/or US Postal Service Priority Mail (for PO Boxes only) to the US consignees (OCD Direct, Drop-Ship and US Federal Government) to inform them of the issue and advise them of the required actions. Immediately install the most recent ADD using the All Assay Data option. If any of your calibrations are expired, the system will post PZB-005 condition codes. Perform calibrations prior to using those reagents. As expected, calibrations that will expire within one hour will also be flagged. Continue to install the most recent ADD at least once each week using the All Assay Data load option so that the system properly flags expired calibrations. --- Foreign affiliates were informed by e-mail on 11/19/2014 of the issue and instructed to notify their consignees of the issue and required actions.
Retiro De Equipo (Recall) de Device Recall VITROS 4600 Chemistry System
  • Tipo de evento
    Recall
  • ID del evento
    69830
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0968-2015
  • Fecha de inicio del evento
    2014-11-19
  • Fecha de publicación del evento
    2015-01-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-05-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131870
  • 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
    Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
  • Causa
    Software anomaly: the firm has identified an anomaly with vitros system software version 3.1 and below, and determined that the software may not properly identify an expired calibration.
  • Acción
    On 11/19/2014, IMPORTANT PRODUCT CORRECTION NOTIFICATION letter (Ref. CL2014-296, dated 11/19/2014) was sent via FedEx overnight courier or ORTHO PLUS e-Communications and/or US Postal Service Priority Mail (for PO Boxes only) to the US consignees (OCD Direct, Drop-Ship and US Federal Government) to inform them of the issue and advise them of the required actions. Immediately install the most recent ADD using the All Assay Data option. If any of your calibrations are expired, the system will post PZB-005 condition codes. Perform calibrations prior to using those reagents. As expected, calibrations that will expire within one hour will also be flagged. Continue to install the most recent ADD at least once each week using the All Assay Data load option so that the system properly flags expired calibrations. --- Foreign affiliates were informed by e-mail on 11/19/2014 of the issue and instructed to notify their consignees of the issue and required actions.
Retiro De Equipo (Recall) de Device Recall VITROS 5600 Integrated System
  • Tipo de evento
    Recall
  • ID del evento
    69830
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0969-2015
  • Fecha de inicio del evento
    2014-11-19
  • Fecha de publicación del evento
    2015-01-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-05-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131874
  • 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
    Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
  • Causa
    Software anomaly: the firm has identified an anomaly with vitros system software version 3.1 and below, and determined that the software may not properly identify an expired calibration.
  • Acción
    On 11/19/2014, IMPORTANT PRODUCT CORRECTION NOTIFICATION letter (Ref. CL2014-296, dated 11/19/2014) was sent via FedEx overnight courier or ORTHO PLUS e-Communications and/or US Postal Service Priority Mail (for PO Boxes only) to the US consignees (OCD Direct, Drop-Ship and US Federal Government) to inform them of the issue and advise them of the required actions. Immediately install the most recent ADD using the All Assay Data option. If any of your calibrations are expired, the system will post PZB-005 condition codes. Perform calibrations prior to using those reagents. As expected, calibrations that will expire within one hour will also be flagged. Continue to install the most recent ADD at least once each week using the All Assay Data load option so that the system properly flags expired calibrations. --- Foreign affiliates were informed by e-mail on 11/19/2014 of the issue and instructed to notify their consignees of the issue and required actions.
Retiro De Equipo (Recall) de Device Recall ADVIA Chemistry Systems Lipase
  • Tipo de evento
    Recall
  • ID del evento
    70835
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1457-2015
  • Fecha de inicio del evento
    2015-03-23
  • Fecha de publicación del evento
    2015-04-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-12-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135046
  • 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
    Lipase-esterase, enzymatic, photometric, lipase - Product Code CHI
  • Causa
    Siemens internal investigation confirmed that current contamination avoidance settings do not prevent carryover resulting in falsely elevated advia chemistry lipase outlier results when running with triglycerides, triglycerides_2, triglycerides_c, cholesterol concentrated, and dldl reagents.
  • Acción
    Siemens issued an Urgent Medical Device Correction on March 23, 2015, notifying direct consignees about the product, problem, and action to be taken. Customers were instructed to follow the directions provided in the customer letter in the event that a Lipase outlier is observed. All customers were requested to complete and return the Effectiveness Check questionnaire attached to the Urgent Medical Device Correction letter within (30) days. Field service personnel have been sent an SKB (Service Knowledge Base) describing the issue and instructing them how to deal with customer questions. For further questions please call (312) 275-7795.
Retiro De Equipo (Recall) de Device Recall Dimension Vista Myoglobin Calibrator
  • Tipo de evento
    Recall
  • ID del evento
    69937
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0946-2015
  • Fecha de inicio del evento
    2014-11-24
  • Fecha de publicación del evento
    2015-01-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-12-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132004
  • 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
    Calibrator, secondary - Product Code JIT
  • Causa
    Dimension vista myoglobin calibrator (myo cal) may produce a positive shift in myo qc and patient test results that exceeds acceptance criteria for this product. a positive shift observed up to 12% at myo concentrations within and above the reference range of the assay. depending on quality control limits, this drift may not be detected.
  • Acción
    The firm, Siemens, sent an "Urgent Medical Device Recall"letter dated November 2014, to all customers who received the affected lot. The letter described the product, problem and actions to be taken. The customers were instructed to: Review this letter with your Medical Director; discard your remaining inventory; recalibrate with an alternate in-date lot of MYO CAL, and complete and return the attached Field Correction Effectiveness Check Form and fax the form to (312) 275-7795. Siemens will replace any unused inventory of the affected lot at no charge. If you have any questions, please contact your Siemens Customer Care Center - Technical Solutions at 800-441-9250 or your local Siemens technical support representative.
Retiro De Equipo (Recall) de Device Recall RTH8 Rotor
  • Tipo de evento
    Recall
  • ID del evento
    69946
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0857-2015
  • Fecha de inicio del evento
    2014-12-03
  • Fecha de publicación del evento
    2014-12-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-11-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132012
  • 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
    Centrifuges (micro, ultra, refrigerated) for clinical use - Product Code JQC
  • Causa
    Iris international is recalling the rth8 rotor used in the statspin express 4 horizontal centrifuge because the rth8 rotor may develop cracks with use over time.
  • Acción
    A customer notification letter dated 12/3/14 was sent to all customers to inform them that Iris International is recalling the RTH8 Rotor used in the StatSpin Express 4 Horizontal Centrifuge because the RTH8 rotor may develop cracks with use over time. The letter informs the customers of the problems identified and the actions to be taken. Beckman Coulter will be managing the logistics of the recall notice. Customers with questions are instructed to contact Customer Technical Support at (800) 854-3633 or via website at http://www.beckmancoulter.com.
Retiro De Equipo (Recall) de Device Recall Beckman Coulter, Lipase Assay
  • Tipo de evento
    Recall
  • ID del evento
    70030
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1023-2015
  • Fecha de inicio del evento
    2014-12-15
  • Fecha de publicación del evento
    2015-01-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-02-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132158
  • 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
    Radioimmunoassay, total thyroxine - Product Code CDT
  • Causa
    N-acetyl cysteine (nac), when administered in therapeutic concentrations for the treatment of acetaminophen overdose, interferes with the assays for these analytes: cholesterol osr6x16, uric acid osr6x98, lactate osr6x93, and lipase osr6x30. nac interference may lead to falsely low results.
  • Acción
    A customer notification letter was sent to their customers on 12/15/14 to inform them that Beckman Coulter has recently confirmed that N-Acetyl Cysteine (NAC), when administered in therapeutic concentrations (for the treatment of acetaminophen overdose), has been determined to interfere with assays for the following analytes: Cholesterol OSR6X16, Uric Acid OSR6X98, Lactate OSR6X93, and Lipase OSR6X30. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with questions are instructed to call (800) 223-0130 in the US and Canada. Customers outside the US and Canada are instructed to contact their local Beckman Coulter Representative.
Retiro De Equipo (Recall) de Device Recall Beckman Coulter, Uric Acid Assay
  • Tipo de evento
    Recall
  • ID del evento
    70030
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1024-2015
  • Fecha de inicio del evento
    2014-12-15
  • Fecha de publicación del evento
    2015-01-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-02-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132159
  • 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
    Acid, uric, uricase (colorimetric) - Product Code KNK
  • Causa
    N-acetyl cysteine (nac), when administered in therapeutic concentrations for the treatment of acetaminophen overdose, interferes with the assays for these analytes: cholesterol osr6x16, uric acid osr6x98, lactate osr6x93, and lipase osr6x30. nac interference may lead to falsely low results.
  • Acción
    A customer notification letter was sent to their customers on 12/15/14 to inform them that Beckman Coulter has recently confirmed that N-Acetyl Cysteine (NAC), when administered in therapeutic concentrations (for the treatment of acetaminophen overdose), has been determined to interfere with assays for the following analytes: Cholesterol OSR6X16, Uric Acid OSR6X98, Lactate OSR6X93, and Lipase OSR6X30. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with questions are instructed to call (800) 223-0130 in the US and Canada. Customers outside the US and Canada are instructed to contact their local Beckman Coulter Representative.
Retiro De Equipo (Recall) de Device Recall Beckman Coulter, Cholesterol Assay
  • Tipo de evento
    Recall
  • ID del evento
    70030
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1025-2015
  • Fecha de inicio del evento
    2014-12-15
  • Fecha de publicación del evento
    2015-01-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-02-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132162
  • 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
    Enzymatic esterase--oxidase, cholesterol - Product Code CHH
  • Causa
    N-acetyl cysteine (nac), when administered in therapeutic concentrations for the treatment of acetaminophen overdose, interferes with the assays for these analytes: cholesterol osr6x16, uric acid osr6x98, lactate osr6x93, and lipase osr6x30. nac interference may lead to falsely low results.
  • Acción
    A customer notification letter was sent to their customers on 12/15/14 to inform them that Beckman Coulter has recently confirmed that N-Acetyl Cysteine (NAC), when administered in therapeutic concentrations (for the treatment of acetaminophen overdose), has been determined to interfere with assays for the following analytes: Cholesterol OSR6X16, Uric Acid OSR6X98, Lactate OSR6X93, and Lipase OSR6X30. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with questions are instructed to call (800) 223-0130 in the US and Canada. Customers outside the US and Canada are instructed to contact their local Beckman Coulter Representative.
Retiro De Equipo (Recall) de Device Recall Beckman Coulter, Lactate Assay
  • Tipo de evento
    Recall
  • ID del evento
    70030
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1026-2015
  • Fecha de inicio del evento
    2014-12-15
  • Fecha de publicación del evento
    2015-01-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-02-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132163
  • 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
    Acid, lactic, enzymatic method - Product Code KHP
  • Causa
    N-acetyl cysteine (nac), when administered in therapeutic concentrations for the treatment of acetaminophen overdose, interferes with the assays for these analytes: cholesterol osr6x16, uric acid osr6x98, lactate osr6x93, and lipase osr6x30. nac interference may lead to falsely low results.
  • Acción
    A customer notification letter was sent to their customers on 12/15/14 to inform them that Beckman Coulter has recently confirmed that N-Acetyl Cysteine (NAC), when administered in therapeutic concentrations (for the treatment of acetaminophen overdose), has been determined to interfere with assays for the following analytes: Cholesterol OSR6X16, Uric Acid OSR6X98, Lactate OSR6X93, and Lipase OSR6X30. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with questions are instructed to call (800) 223-0130 in the US and Canada. Customers outside the US and Canada are instructed to contact their local Beckman Coulter Representative.
Retiro De Equipo (Recall) de Device Recall Portex Anaerobic Pulsator Arterial Blood Sampling Kit
  • Tipo de evento
    Recall
  • ID del evento
    70034
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1028-2015
  • Fecha de inicio del evento
    2014-12-17
  • Fecha de publicación del evento
    2015-01-29
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-06-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132165
  • 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
    Tubes, vials, systems, serum separators, blood collection - Product Code JKA
  • Causa
    The outer box label is marked with the correct expiration date of 08/2016. the inner tyvek unit label is marked with 08-2017 which exceeds the actual expiration date by one year.
  • Acción
    Smiths Medical notified American Medical Depot via telephone on 12 December 2014. Smiths Medical instructed them to put product at their location on hold. American Medical Depots customer will be instructed to return their unused product for replacement.
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