Z-0804-2021 Class II Terminated
FDA device recall Z-0804-2021 was initiated by Roche Diagnostics Operations, Inc. on December 2, 2020 and is designated Class II. Reason for recall: Possible Misinterpretation of Displayed Measuring Units from INR to %Quick or Seconds; providing instructions to users for ensuring the meter is displaying INR results The recall status is terminated (terminated June 30, 2022). Affected quantity: 716,880 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 13, 2021
- Initiation Date
- December 2, 2020
- Termination Date
- June 30, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 716,880 units
Product 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
Reason for Recall
Possible Misinterpretation of Displayed Measuring Units from INR to %Quick or Seconds; providing instructions to users for ensuring the meter is displaying INR results
Distribution Pattern
US Nationwide
Code Information
All serial numbers