bioMerieux VITEK 2 Gram Positive Cefoxitin Screen — Class I medical device recall Z-2817-2018
Terminated recall by bioMerieux, Inc., reported 2018-08-29, distributed nationwide. Customer reports indicated an increase in the rate of non-detected MRSA in association with the VITEK 2 AST-P6
| Recall number | Z-2817-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | bioMerieux, Inc., Durham, NC, United States |
| Recall initiated | 2018-01-26 |
| Classified | 2018-08-17 |
| Reported by FDA | 2018-08-29 |
| Terminated | 2019-05-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | BM, BR, CA, CN, CR, CW, DO, EC, FR, GT, HK, ID, IL, KR, MX, NI, PE, PH, PY, SG, SV, TH, VN, ZA |
| Quantity | 13,961,320 us |
| UPC / GTIN / UDI-DI | 03573026242060, 03573026355173, 03573026426804, 03573026437183, 03573026553982 |
| Model numbers | 22226, 410750, 414961, 415670, 421051 |
Product
bioMerieux VITEK 2 Gram Positive Cefoxitin Screen, VITEK 2 Gram Positive AST for Oxacillin, VITEK SYSTEMS General Susceptibility Card Cefotoxin and AST for Oxacillin bioMerieux VITEK 2 AST-P631 bioMerieux VITEK 2 AST-GP67 Test Kit bioMerieux VITEK 2 AST-GP71 Test Kit bioMerieux VITEK 2 AST-GP75 Test Kit bioMerieux VITEK 2 AST-GP78 Test Kit Components for an automated invitro diagnostic system consisting of instruments, software and reagent cards designed for the ID and antimicrobial susceptibility testing of bacteria and yeast.
Reason for recall
Customer reports indicated an increase in the rate of non-detected MRSA in association with the VITEK 2 AST-P631 product.
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-2817-2018. 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.