FDA Device recall Z-1642-2016
Vitek 2 Gram Positive Susceptibility Test Cards (AST-P641 REF 418590), 20 cards/kit
- FDA Device
- Class I
- terminated
- Published 2016-05-18
On 2016-05-18 the FDA classified a Class I recall of Vitek 2 Gram Positive Susceptibility Test Cards (AST-P641 REF 418590), 20 cards/kit by Biomerieux, citing product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1642-2016 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2016-02-24 |
| Published | 2016-05-18 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Biomerieux |
| Distribution | n/a |
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
Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.
Identifiers
| code_info | Lots 741340920 exp. 4/14/16, 741350820 exp. 7/22/16, 741356320 exp. 9/15/16, 741357020 exp. 9/22/16, and 741366820 exp. 12/29/16. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1642-2016%22
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