Recall Z-0803-2021 ยท GJS Test, Time, Prothrombin
Roche Diagnostics Operations, Inc.
CoaguChek XS Prof (Professional) Meters- IVD professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy. Catalog: 04837975001 Units could consist of any of the following strip configurations: 6 count, 24 count, 2x 24 count (i.e. 48 strips)* *CoaguChek XS 3x48 promo LTC HH Catalog: 06298176001 CoaguChek XS 6x24 promo LTC HH Catalog:084686
| 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 | 212,093 units |
| Distribution | US Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060978 | COAGUCHEK XS SYSTEM Roche Diagnostics, Aug 11, 2006 |