VITEK 2 Systems and VITEK 2 with MYLA — Class II medical device recall Z-1059-2022
Ongoing recall by bioMerieux, Inc., reported 2022-05-18, distributed in NC. Software issue where results sent to the LIS via HL7 format for antibiotic screen tests and synergy tests do n
| Recall number | Z-1059-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | bioMerieux, Inc., Durham, NC, United States |
| Recall initiated | 2022-03-29 |
| Classified | 2022-05-11 |
| Reported by FDA | 2022-05-18 |
| Distributed | NC |
| Countries outside the US | AR, AT, AU, BE, BR, CA, CH, CL, CN, CO, CZ, DE, EG, ES, FI, FR, GB, GR, HU, IN, IT, JP, KR, MX, NL, NO, PH, PL, PT, RS, RU, SE, SG, TH, TR, ZA |
| Quantity | 21,757 systems |
| Reason classes | software |
Product
VITEK 2 Systems and VITEK 2 with MYLA.
Reason for recall
Software issue where results sent to the LIS via HL7 format for antibiotic screen tests and synergy tests do not include the user-corrected or AES-corrected interpretation. This can potentially lead to incorrect final screen/synergy test results at the LIS.
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-1059-2022. 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.