FDA Device recall Z-2348-2017
VITEK 2 Gram Negative Susceptibility card (AST-GN13), REF 22095, 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-GN13), REF 22095, 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-2348-2017 |
| 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-GN13), REF 22095, 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 | 1100152203 27/Apr/18 1100180103 25/May/18 1100201103 15/Jun/18 1100252203 05/Aug/18 1100258203 11/Aug/18 1100259203 12/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-2348-2017%22
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