bioMerieux Vitek 2 Systems Software version 6 — Class II medical device recall Z-1914-2013
Terminated recall by Biomerieux Inc, reported 2013-08-14, distributed nationwide. A product issue has been identified for customers using software version 6.01 and are interfaced with a Labora
| Recall number | Z-1914-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomerieux Inc, Hazelwood, MO, United States |
| Recall initiated | 2013-06-14 |
| Classified | 2013-08-06 |
| Reported by FDA | 2013-08-14 |
| Terminated | 2015-06-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BG, BH, BR, CA, CH, CL, CN, CR, CZ, DE, DO, EC, EG, ES, FR, GB, HK, HR, HU, ID, IL, IN, IT, JP, KR, KW, LT, MA, MT, MX, MY, NG, NI, NL, PA, PE, PH, PK, PL, PT, RO, RS, RU, SE, SG, SI, TH, TN, UY, VN, ZA |
| Quantity | 12,384 kits |
| Reason classes | software |
| Model numbers | 414563 |
Product
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 IT. Part number: 414563. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast.
Reason for recall
A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from version 5.xx to 6.01, the Bid-directional Computer interface (BCI) antibiotic codes are not updated properly for Cefovecin, Prulifloxacin and Ceftaroline. For the referenced antibiotics, the firm code in the reference table
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-1914-2013. 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.