Vitek 2 Gram Positive Susceptibility Test Cards — Class I medical device recall Z-1642-2016
Terminated recall by Biomerieux Inc, reported 2016-05-18. Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.
| Recall number | Z-1642-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomerieux Inc, Hazelwood, MO, United States |
| Recall initiated | 2016-02-24 |
| Classified | 2016-05-11 |
| Reported by FDA | 2016-05-18 |
| Terminated | 2018-03-08 |
| Countries outside the US | CH, CN, CZ, HK, HU, JP, PL, TR, ZA |
| Quantity | 3,594 kits |
| Lot numbers | 741340920, 741350820, 741356320, 741357020, 741366820 |
| Model numbers | 418590 |
| Expiration dates | 2016-04-14, 2016-07-22, 2016-09-15, 2016-09-22, 2016-12-29 |
Product
Vitek 2 Gram Positive Susceptibility Test Cards (AST-P641 REF 418590), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed in the Product Information manual.
Reason for recall
Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.
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-1642-2016. 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.