Biomerieux Inc recalls Vitek 2 AST-P640 REF 418 579 Gram Positive Susceptibility Card, 20 cards per container, IVD. Intended for use with the…

Recall date

February 25, 2015

Source

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

Recall number

Z-1402-2015

FDA classification

Class III

Brand / firm

Biomerieux Inc

Sold / distributed

Worldwide Distribution to United Kingdom and Turkey. NO U.S. distribution.

Why it was recalled

The outer carton label and package insert for the recalled product incorrectly lists Streptococcus pneumoniae as an organism for intended use.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Vitek 2 AST-P640 REF 418 579 Gram Positive Susceptibility Card, 20 cards per container, IVD. Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae.