Recall Z-1401-2015 — 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.
U.S. FDA — Device Enforcement · United States · 2015-02-25 · Class III
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Reported risk: The outer carton label and package insert for the recalled product incorrectly lists Streptococcus pneumoniae as an organism for intended use.
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