CoaguChek¿ XS System Prothrombin time test: CoaguChek XS PT Test 2X24… — Class I medical device recall Z-0360-2019
Terminated recall by Roche Diagnostics Corporation, reported 2018-11-14, distributed nationwide. Abnormally high INR test results with the affected CoaguChek test strips
| Recall number | Z-0360-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Roche Diagnostics Corporation, Indianapolis, IN, United States |
| Recall initiated | 2018-09-13 |
| Classified | 2018-11-02 |
| Reported by FDA | 2018-11-14 |
| Terminated | 2020-10-16 |
| Distributed | Nationwide (US) |
| Quantity | 1,163,952 boxes |
| Model numbers | 04625315160, 04625374160, 04625375160, 07797826160 |
Product
CoaguChek¿ XS System Prothrombin time test: CoaguChek XS PT Test 2X24 Strips, Catalog Number: 04625315160; CoaguChek XS PT Test 6 Strips, Catalog Number: 04625374160; CoaguChek XS PT Test 24 Tests, Catalog Number: 07797826160;
Reason for recall
Abnormally high INR test results with the affected CoaguChek test strips
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-0360-2019. 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.