Vitek 2 Gram Positive Susceptibility Test Cards — Class I medical device recall Z-1643-2016

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-1643-2016`
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	15,006 kits
Lot numbers	`742343610`, `742347220`, `742350010`, `742352820`, `742355710`, `742362540`, `742364020`, `742368210`, `742376540`, `742383610`, `742389220`
Model numbers	`418604`
Expiration dates	`2016-01-12`, `2016-05-11`, `2016-06-16`, `2016-07-14`, `2016-08-11`, `2016-09-09`, `2016-11-16`, `2016-12-01`, `2017-04-05`, `2017-06-15`, `2017-08-10`

Product

Vitek 2 Gram Positive Susceptibility Test Cards (AST-P642 REF 418604), 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-1643-2016. 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.