RecallRadar

FDA Device recall Z-2380-2017

VITEK¿ 2 Gram Negative Susceptibility card (AST-GN49), REF 412091, 20 cards per carton

On 2017-06-21 the FDA classified a Class II recall of VITEK¿ 2 Gram Negative Susceptibility card (AST-GN49), REF 412091, 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

AgencyFDA Device
Recall numberZ-2380-2017
ClassificationClass II
Statusterminated
Initiated2017-04-20
Published2017-06-21
Last updated2026-09-13 11:54 UTC
CompanyBiomerieux
DistributionUS

Product

VITEK¿ 2 Gram Negative Susceptibility card (AST-GN49), REF 412091, 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
4690028203 24/Dec/17 4690167103 12/May/18 4690168103 13/May/18 4690187103 01/Jun/18 4690197203 11/Jun/18 469020810…4690028203 24/Dec/17 4690167103 12/May/18 4690168103 13/May/18 4690187103 01/Jun/18 4690197203 11/Jun/18 4690208103 22/Jun/18 4690224203 08/Jul/18 4690229103 13/Jul/18 4690230103 14/Jul/18 4690237103 21/Jul/18 4690254203 07/Aug/18 4690265203 18/Aug/18 4690272103 25/Aug/18 4690277203 30/Aug/18 4690287203 09/Sep/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-2380-2017%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.