Recall Z-2003-2009 ยท GJS Test, Time, Prothrombin
Roche Diagnostics Operations, inc.
Roche CoaguChek XS System, CoaguChek XS PST Kit, Roche Diagnostics, Indianapolis, IN; Catalog/Model Number 04837738001. CoaguChek XS System and CoaguChek XS Plus System are point of care monitoring devices for people taking oral anticoagulation medication.
| Date | Sep 3, 2009 (initiated Jul 22, 2009) |
| Status | Terminated |
| Reason | The recommended cleaning procedures for the meter may cause a malfunction and falsely elevated test result reports. |
| Root cause | Device Design |
| Action | 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. |
| Quantity | 27,784 in US |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062925 | COAGUCHEK XS SYSTEM Roche Diagnostics Corp., Jan 29, 2007 |