FDA Device recall Z-2351-2017
VITEK 2 Gram Negative Susceptibility card (AST-GN16), REF 22139, 20 cards per carton
- FDA Device
- Class II
- terminated
- Published 2017-06-21
On 2017-06-21 the FDA classified a Class II recall of VITEK 2 Gram Negative Susceptibility card (AST-GN16), REF 22139, 20 cards per carton by Biomerieux, citing the integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2351-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-04-20 |
| Published | 2017-06-21 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Biomerieux |
| Distribution | US |
Product
VITEK 2 Gram Negative Susceptibility card (AST-GN16), REF 22139, 20 cards per carton.
Reason
The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
Identifiers
| code_info | 1130069203 03/Feb/18 1130173203 18/May/18 1130192103 06/Jun/18 1130227203 11/Jul/18 1130266103 19/Aug/18 |
|---|
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-2351-2017%22
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