Device product
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
Z-0804-2021
Product summary
- Event
- Event 86951
- Status
- Terminated
- Classification
- Class II
- Quantity
- 716,880 units
- Official record key
device-enforcement:Z-0804-2021
Official wording
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
Code information: All serial numbers
Distribution pattern: US Nationwide
Derived failure modes
-
Unknown
Possible Misinterpretation of Displayed Measuring Units from INR to %Quick or Seconds; providing instructions to users for ensuring the meter is displaying INR results