FDA Device recall Z-0804-2021
CoaguChek XS PST Meters- IVD (Patient Self-Testing) measures blood-clotting time for people who are taking anticoagulation medications such…
- FDA Device
- Class II
- terminated
- Published 2021-01-13
On 2021-01-13 the FDA classified a Class II recall of CoaguChek XS PST Meters- IVD (Patient Self-Testing) measures blood-clotting time for people who are taking anticoagulation medications such… by Roche Diagnostics Operations, citing possible Misinterpretation of Displayed Measuring Units from INR to %Quick or Seconds; providing instructions to users for ensuring the meter is displaying INR results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0804-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-12-02 |
| Published | 2021-01-13 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Roche Diagnostics Operations |
| Distribution | US |
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
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
Identifiers
| code_info | All serial numbers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0804-2021%22
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