ETEST Benzyl Penicillin PG256 FOAM packaging — Class II medical device recall Z-1527-2017
Terminated recall by BioMerieux SA, reported 2017-03-29, distributed nationwide. Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal te
| Recall number | Z-1527-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | BioMerieux SA, Marcy L'Etoile, France |
| Recall initiated | 2016-12-15 |
| Classified | 2017-03-21 |
| Reported by FDA | 2017-03-29 |
| Terminated | 2020-08-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | AF, AR, AT, AU, BG, BH, BO, BR, CA, CH, CL, CO, CR, CZ, DE, DO, DZ, EC, EE, EG, ES, FR, GB, GR, GT, HK, HN, HR, ID, IL, IN, IR, IT, JO, JP, KE, KR, KW, LB, LT, LV, MA, MT, MX, MY, NG, NI, NL, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, RS, SA, SE, SG, SI, SV, TH, TN, TR, UY, VE, VN, ZA |
| Reason classes | specification failure |
| Lot numbers | 1002911350, 1002964350, 1003012790, 1003036730, 1003142000, 1003191650, 1003408580, 1004047370, 1004047410, 1004139950, 1004140000, 1004242300, 1004244180, 1004420440, 1004539350, 1004539950, 1004783760, 1004783810, 1004872350, 1004872380, 1004896600, 1004910650, 1004985540 |
Product
ETEST Benzyl Penicillin PG256 FOAM packaging, Product Name: Etest Benzylpenicillin PG 0.016-256 (high). ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species and fastidious bacteria, such as anaerobes, N. gonorrhoeae, S. pneumoniae, Streptococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC), in ¿g/mL, of different antimicrobial agents against microorganisms as tested on agar media using overnight incubation. Current Antimicrobial Susceptibility Testing (AST) methods are based either on quantitative dilution techniques or qualitative diffusion procedures. Dilution methods are based on two-fold serial dilutions of antibiotics in broth or agar media. These methods generate the MIC value i.e. Minimum Inhibitory Concentration of a given antibiotic in ¿g/mL that will inhibit the growth of a particular bacterium under defined experimental conditions
Reason for recall
Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing.
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-1527-2017. 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.