Roche Diagnostics Operations, Inc. Recall 86951
Description: CoaguChek XS PST Meters- IVD (Patient Self-Testing) measures blood-clotting time for people who are taking anticoagulation medications such as Coumadin or warfarin. Catalog 04837738001
Roche Diagnostics Operations, Inc. Recall 86951 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0804-2021 |
| Event ID | 86951 |
| Event Description | CoaguChek XS PST Meters- IVD (Patient Self-Testing) measures blood-clotting time for people who are taking anticoagulation medications such as Coumadin or warfarin. Catalog 04837738001 |
| Product Type | Devices |
| Distribution | US Nationwide |
| Quantity | 716,880 units |
| Recall Reason | Possible Misinterpretation of Displayed Measuring Units from INR to %Quick or Seconds; providing instructions to users for ensuring the meter is displaying INR results |
| Device Classification | 20210113 |
| Device Code Info | All serial numbers |
| Center Classification Date | 20210107 |
| Recall Initiation Date | 20201202 |
| Recalling Firm | Roche Diagnostics Operations, Inc. |
| Initial Notification | Letter |
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