Recall Z-2429-2017— Biomerieux Inc

Name: FDA recall Z-2429-2017
Creator: U.S. Food and Drug Administration
Published: 2017-04-20

Class II · Terminated

Class II FDA medical device recall by Biomerieux Inc, initiated 2017-04-20, terminated 2020-07-22. FDA's recall record names no specific 510(k) clearance for this event. Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-GN81), REF 413438, 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)..

Recalling firm: Biomerieux Inc
Classification: Class II
Status: Terminated
Initiated: 2017-04-20
Terminated: 2020-07-22
Firm location: Hazelwood, MO, United States

Product description

VITEK¿ 2 Gram Negative Susceptibility card (AST-GN81), REF 413438, 20 cards per carton.

Reason for recall

The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).

Data sourced from openFDA. This site is unofficial and independent of the FDA.