Creatinine — Class II medical device recall Z-0958-2013
Terminated recall by Beckman Coulter Inc., reported 2013-03-27, distributed nationwide. Beckman Coulter is including additional information and instructions in the Creatinine (OSR6x78) IFU and Setti
| Recall number | Z-0958-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2012-12-28 |
| Classified | 2013-03-15 |
| Reported by FDA | 2013-03-27 |
| Terminated | 2013-10-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | BR, CA, CO, CR, EC, HN, MX, PE, VE |
| Reason classes | specification failure |
| Model numbers | OSR6178, OSR6678 |
Product
Creatinine, Part Numbers OSR6178, OSR6678 Product Usage: System reagent for the quantitative determination of Creatinine in human serum and urine on Beckman Coulter AU analyzers.
Reason for recall
Beckman Coulter is including additional information and instructions in the Creatinine (OSR6x78) IFU and Setting Sheet, relating to calibration stability and quality control frequency to assure product performance.
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-0958-2013. 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.