FDA Device recall Z-1403-2015
Vitek 2 AST-P641 REF 418 590 Gram Positive Susceptibility Card, 20 cards per carton, IVD. Intended for use with the Vitek 2 Systems in clin…
- FDA Device
- Class III
- terminated
- Published 2015-04-15
On 2015-04-15 the FDA classified a Class III recall of Vitek 2 AST-P641 REF 418 590 Gram Positive Susceptibility Card, 20 cards per carton, IVD. Intended for use with the Vitek 2 Systems in clin… 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-1403-2015 |
| 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-P641 REF 418 590 Gram Positive Susceptibility Card, 20 cards per carton, 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 741350820, expiration 22JUL16; lot 741340920, expiration 14APR16; |
|---|
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-1403-2015%22
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