Creatine Kinase — Class II medical device recall Z-3187-2024
Ongoing recall by Roche Diagnostics Operations, Inc., reported 2024-10-02, distributed nationwide. Creatine Kinase (CK) Assay Abnormal calibrations on the cobas¿ c 311/501/502 and COBAS INTEGRA 400 plus Analyz
| Recall number | Z-3187-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Roche Diagnostics Operations, Inc., Indianapolis, IN, United States |
| Recall initiated | 2024-08-15 |
| Classified | 2024-09-20 |
| Reported by FDA | 2024-10-02 |
| Distributed | Nationwide (US) |
| Quantity | 6,504 units |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 04015630940806 |
| Lot numbers | 755471 |
| Model numbers | 07190794190 |
| Expiration dates | 2024-06-30 |
Product
Creatine Kinase (CK) used on cobas c 311/501/502 and COBAS INTEGRA 400 plus-In vitro test for the quantitative determination of creatine kinase (CK) in human serum and plasma. Catalog Number: 07190794190
Reason for recall
Creatine Kinase (CK) Assay Abnormal calibrations on the cobas¿ c 311/501/502 and COBAS INTEGRA 400 plus Analyzers may lead to erroneous results and misdiagnosis.
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-3187-2024. 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.