ETEST OXACILLIN OX 256 US F100 In vitro diagnostic — Class II medical device recall Z-0264-2018
Terminated recall by BioMerieux SA, reported 2017-12-27, distributed nationwide. QC failures (MIC out of range high) for S.aureus ATCC 29213 strain on ETEST OX 256 (OXACILLIN) Foam packaging
| Recall number | Z-0264-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | BioMerieux SA, Marcy L'Etoile, France |
| Recall initiated | 2017-04-13 |
| Classified | 2017-12-19 |
| Reported by FDA | 2017-12-27 |
| Terminated | 2020-08-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, CA, CH, CZ, DE, DZ, EE, EG, ES, FR, GB, GR, HK, HR, HU, IL, IN, IT, JP, KR, KW, LB, MT, MX, NG, NL, PE, PH, QA, SA, SE, SI, TH, TR, ZA |
| Quantity | 1,585 units |
| Pathogens | staphylococcus |
| Lot numbers | 1003059010, 1003315830, 1004071250, 1004818860, 1004890400 |
| Model numbers | 520558 |
Product
ETEST OXACILLIN OX 256 US F100 In vitro diagnostic, a quantitative technique for determining the antimicrobial susceptibility of bacteria species.
Reason for recall
QC failures (MIC out of range high) for S.aureus ATCC 29213 strain on ETEST OX 256 (OXACILLIN) Foam packaging (Ref. 520558, 520518) reported. The product behavior could lead to False Resistant results.
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-0264-2018. 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.