VITEK 2 Gram Negative test kits containing colistin — Class II medical device recall Z-2770-2017
Terminated recall by Biomerieux Inc, reported 2017-08-02, distributed in NC. The investigation demonstrated a high rate of very major errors (resistant isolates calling susceptible) with
| Recall number | Z-2770-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomerieux Inc, Hazelwood, MO, United States |
| Recall initiated | 2017-05-16 |
| Classified | 2017-07-27 |
| Reported by FDA | 2017-08-02 |
| Terminated | 2019-06-19 |
| Distributed | NC |
| Countries outside the US | AR, AT, BR, CA, CL, CN, CO, CR, DE, DO, EC, ES, FR, GB, GT, HK, IL, IN, IT, JP, KR, MX, MY, NI, NL, PA, PE, PH, PL, PY, SG, TH, TR, UY, VE, VN, ZA |
| Quantity | 1,520,000 cards |
| Model numbers | 22258, 410025, 412605, 412862, 412863, 412918, 412921, 412924, 413061, 413083, 413112, 413171, 413172, 413204, 413205, 413230, 413391, 413394, 413397, 413572, 413722, 413724, 413725, 413753, 414164 and 46 more |
Product
VITEK 2 Gram Negative test kits containing colistin (cs01n)
Reason for recall
The investigation demonstrated a high rate of very major errors (resistant isolates calling susceptible) with the VITEK¿ 2 AST-GN colistin (cs01n) compared to agar dilution (the reference method used for cs01n development) and compared to broth-microdilution (recommended method by EUCAST/CLSI).
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-2770-2017. 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.