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Biomerieux Inc recalls Vitek 2 AST-P635 REF 416 911 Gram Positive Susceptibility Card, 20 cards per container, IVD. Intended for use with t
Recalled April 15, 2015 · FDA recall Z-1401-2015 · Biomerieux
Hazard
The outer carton label and package insert for the recalled product incorrectly lists Streptococcus pneumoniae as an organism for intended use. · FDA Class III
Units
10409 cartons
Sold at
Worldwide Distribution to United Kingdom and Turkey. NO U.S. distribution.
Description
The outer carton label and package insert for the recalled product incorrectly lists Streptococcus pneumoniae as an organism for intended use.
Product
Vitek 2 AST-P635 REF 416 911 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.
Manufacturer(s)
Biomerieux Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →