FDA Device recall Z-1402-2015
Vitek 2 AST-P640 REF 418 579 Gram Positive Susceptibility Card, 20 cards per container, IVD. Intended for use with the Vitek 2 Systems in c…
- FDA Device
- Class III
- terminated
- Published 2015-04-15
On 2015-04-15 the FDA classified a Class III recall of Vitek 2 AST-P640 REF 418 579 Gram Positive Susceptibility Card, 20 cards per container, IVD. Intended for use with the Vitek 2 Systems in c… by Biomerieux, citing the outer carton label and package insert for the recalled product incorrectly lists Streptococcus pneumoniae as an organism for intended use.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1402-2015 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2015-02-25 |
| Published | 2015-04-15 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Biomerieux |
| Distribution | n/a |
Product
Vitek 2 AST-P640 REF 418 579 Gram Positive Susceptibility Card, 20 cards per container, IVD. Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae.
Reason
The outer carton label and package insert for the recalled product incorrectly lists Streptococcus pneumoniae as an organism for intended use.
Identifiers
| code_info | lot 740340920, expiration 14APR16; lot 740350820, expiration 22JUL16; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1402-2015%22
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