Medical device recalls Moderate risk

Biomerieux Inc recalls VITEK¿ 2 Gram Negative Susceptibility card (AST-N237), REF 413172, 20 cards per carton.

Recall date
April 20, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2410-2017
FDA classification
Class II
Brand / firm
Biomerieux Inc
Sold / distributed
Nationwide distribution in the U.S, including military and government sites. The product was also distributed to Algeria, Angola, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia - Herzegovina, Brazil, Brunei, Bulgaria, Burkina Faso, Cambodia, Cameroun, Canada, Chad, Chi…

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

VITEK¿ 2 Gram Negative Susceptibility card (AST-N237), REF 413172, 20 cards per carton.

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