Etest¿ Ceftaroline — Class III medical device recall Z-0231-2015
Terminated recall by Biomerieux, reported 2014-11-26, distributed nationwide. The products have a wrong expiration date on their labeling, 5 years instead of 2 years.
| Recall number | Z-0231-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomerieux, Letoile, N/A, France |
| Recall initiated | 2014-10-16 |
| Classified | 2014-11-19 |
| Reported by FDA | 2014-11-26 |
| Terminated | 2017-11-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, CH, CN, CZ, DE, EG, FR, GB, IN, IT, JP, NL, PK, PL, PT, SE, SI, TR, UY |
| Quantity | 652 devices |
| Reason classes | labeling |
| Lot numbers | 1003160510 |
| Model numbers | 537508 |
| Expiration dates | 2016-04-27 |
Product
Etest¿ Ceftaroline (CPT32) WWB100. Etest¿ (Antimicrobial Susceptibility Testing) is a quantitative technique for determining the antimicrobial susceptibility of Gram negative and Gram positive aerobic bacteria.
Reason for recall
The products have a wrong expiration date on their labeling, 5 years instead of 2 years.
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-0231-2015. 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.