CoaguChek XS Pro System The CoaguChek XS Pro System — Class II medical device recall Z-1582-2013
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-1582-2013 |
|---|---|
| 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 | 537 meters |
| Model numbers | 05530199160 |
Product
CoaguChek XS Pro System The CoaguChek XS Pro System (CoaguChek XS Pro meter and CoaguChek XS PT Test strips) quantitatively determines prothrombin time ("PT"), using capillary blood or whole blood from a vein (non anticoagulated venous whole blood).
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-1582-2013. 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.