Recall Z-2004-2009
Roche Diagnostics Operations, inc. · initiated July 22, 2009
Product
Roche CoaguChek XS System, CoaguChek XS Plus Care Kit, Roche Diagnostics, Indianapolis, IN; Model Number 05021537001. CoaguChek XS System and CoaguChek XS Plus System are point of care monitoring devices for people taking oral anticoagulation medication.
Codes / lots: All serial numbers.
Reason for recall
The recommended cleaning procedures for the meter may cause a malfunction and falsely elevated test result reports.
FDA-determined cause: Device Design
Action taken
Roche Diagnostics Operations, Inc. notified Consignees by letter dated July 22, 2009 informing them of the problem and instructing them to use revised cleaning procedures. For further questions, contact Roche Diagnostics Operations, Inc. at 1-317-521-3194.
Details
- Recall number
- Z-2004-2009
- Initiated
- July 22, 2009
- Posted by FDA
- September 3, 2009
- Terminated
- April 27, 2011
- Product code
- GJS – Test, Time, Prothrombin
- Quantity
- 1,327 in US
- Distribution
- Worldwide Distribution
- Recalling firm
- Roche Diagnostics Operations, inc., Indianapolis, IN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2002-2009 | Roche CoaguChek XS System, CoaguChek XS Professional Care Kit, Roche Diagnostics…The recommended cleaning procedures for the meter may cause a malfunction and falsely elevated test result… | 07/22/2009Terminated |
| Z-2003-2009 | Roche CoaguChek XS System, CoaguChek XS PST Kit, Roche Diagnostics, Indianapolis, IN…The recommended cleaning procedures for the meter may cause a malfunction and falsely elevated test result… | 07/22/2009Terminated |