VITEK 2 Yeast identification card recalled over mold contamination

Recall date

April 20, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Biomerieux Inc recalls VITEK 2 Yeast identification card (YST), IVD, REF 21343, 20 cards per carton. .

Recall number

Z-2343-2017

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 Yeast identification card (YST), IVD, REF 21343, 20 cards per carton. .