CoaguChek XS System — Class II medical device recall Z-1581-2013
Terminated recall by Roche Diagnostics Operations, Inc., reported 2013-07-03, distributed nationwide. Roche has confirmed the potential for an undetected elevated INR test result with the CoaguChek XS, CoaguChek
| Recall number | Z-1581-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Roche Diagnostics Operations, Inc., Indianapolis, IN, United States |
| Recall initiated | 2013-05-16 |
| Classified | 2013-06-24 |
| Reported by FDA | 2013-07-03 |
| Terminated | 2014-04-16 |
| Distributed | Nationwide (US) |
| Quantity | 204,205 meters |
| Model numbers | 04837738001 |
Product
CoaguChek XS System (PST) The CoaguChek XS PT test strips are part of the CoaguChek XS System. The CoaguChek XS System measures blood-clotting time for people who are taking anticoagulation medications such as Coumadin¿ or warfarin.
Reason for recall
Roche has confirmed the potential for an undetected elevated INR test result with the CoaguChek XS, CoaguChek XS Plus, and CoaguChek XS Pro meters. In rare cases, instead of a value, an ERROR 6 message is displayed.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1581-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.