VITEK¿ 2 Gram Negative Susceptibility card — Class II medical device recall Z-2444-2017
Terminated recall by Biomerieux Inc, reported 2017-06-21, distributed nationwide. The integrity of the product container may be compromised thereby exposing product to moisture which could lea
| Recall number | Z-2444-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomerieux Inc, Hazelwood, MO, United States |
| Recall initiated | 2017-04-20 |
| Classified | 2017-06-13 |
| Reported by FDA | 2017-06-21 |
| Terminated | 2020-07-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BH, BR, CA, CH, CL, CN, CO, CR, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FR, GB, GR, GT, HN, HR, HT, HU, ID, IL, IN, IQ, IT, JO, JP, KE, KR, KW, LB, LK, LT, LV, MA, MT, MX, MY, NG, NL, NO, OM, PA, PE, PH, PK, PL, PT, PY, RO, RS, RU, SA, SE, SG, SI, SV, TH, TN, TR, UA, UY, VE, VN, ZA |
| Quantity | 2,428 cartons |
| Reason classes | potency, specification failure |
| Model numbers | 413943 |
Product
VITEK¿ 2 Gram Negative Susceptibility card (AST-GN87), REF 413943, 20 cards per carton.
Reason for recall
The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
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-2444-2017. 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.