Recall Z-0804-2021 ยท GJS Test, Time, Prothrombin
Roche Diagnostics Operations, Inc.
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
| Date | Jan 7, 2021 (initiated Dec 2, 2020) |
| Status | Terminated |
| 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 |
| Root cause | Device Design |
| Action | Roche issued on 12/2/2020, UMDC letter notifications via UPS Ground (signature required upon receipt) to Healthcare Professionals, Distributors and Patients provides instructions to users for ensuring the meter is displaying INR results as follows: For the CoaguChek XS Pro system: UMDC for Healthcare Professionals (TP-01147); UMDC TP-01150 (Distributors), including an enclosed UMDC for Healthcare Professionals (TP-01147). For the CoaguChek XS PST system: UMDC for IDTFs (TP-01148) Including an enclosed UMDC for Patients (TP-01142);" UMDC for Clinics (TP-01149);o Including an enclosed UMDC |
| Quantity | 716,880 units |
| Distribution | US Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062925 | COAGUCHEK XS SYSTEM Roche Diagnostics Corp., Jan 29, 2007 |