FDA Device recall Z-1645-2016
Vitek 2 Gram Positive Susceptibility Test Cards (AST-P644 REF 418673), 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-P644 REF 418673), 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-1645-2016 |
| 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-P644 REF 418673), 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 744357740 exp. 9/29/16, 744383620 exp. 6/15/17, and 744389320 exp. 8/11/17. |
|---|
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-1645-2016%22
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