VITEK 2 Antimicrobial Susceptibility Testing — Class II medical device recall Z-0618-2019
Terminated recall by bioMerieux, Inc., reported 2018-12-26, distributed nationwide. False resistant results for Streptococcus anginosus and Streptococcus constellatus strains were reported.
| Recall number | Z-0618-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | bioMerieux, Inc., Durham, NC, United States |
| Recall initiated | 2018-10-22 |
| Classified | 2018-12-17 |
| Reported by FDA | 2018-12-26 |
| Terminated | 2019-11-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | BD, BH, DZ, EG, HR, IQ, JO, KE, KW, LB, LK, LT, LV, MA, MT, OM, PK, QA, RO, RS, SA, SI, TN, UA |
| Quantity | 184,374 |
| Model numbers | 410028, 420915, 421040 |
Product
VITEK 2 Antimicrobial Susceptibility Testing (AST) using one or more of these susceptibility products: Catalog # 410028, VITEK 2 AST-ST01 Catalog # 420915, VITEK 2 AST-ST02 Catalog # 421040, VITEK 2 AST-ST03 The VITEK 2 Streptococcus Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of S. pneumoniae, beta-hemolytic Streptococcus, and Viridans Streptococcus to antimicrobial agents when used as instructed.
Reason for recall
False resistant results for Streptococcus anginosus and Streptococcus constellatus strains were reported.
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-0618-2019. 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.