Etest Cefotaxime CT 256 WW and Etest Cefotaxime CT 256 US — Class II medical device recall Z-1947-2015
Terminated recall by BioMerieux SA, reported 2015-07-08, distributed nationwide. QC results were out of range resulting in false resistant strains.
| Recall number | Z-1947-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | BioMerieux SA, Marcy L'Etoile, France |
| Recall initiated | 2015-06-12 |
| Classified | 2015-07-01 |
| Reported by FDA | 2015-07-08 |
| Terminated | 2017-08-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BR, CA, CH, CL, CR, CZ, DE, DZ, ES, FR, GB, GR, HK, HN, IN, IT, JP, KW, NL, PH, PL, SA, SE, SI, TH, TR, VN, ZA |
| Quantity | 674 |
Product
Etest Cefotaxime CT 256 WW and Etest Cefotaxime CT 256 US. in vitro diagnostic.
Reason for recall
QC results were out of range resulting in false resistant strains.
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-1947-2015. 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.