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Biomerieux Inc recalls Vitek 2 Gram Positive Susceptibility Test Cards (AST-P643 REF 418671), 20 cards/kit. Product Usage: The VITEK 2 Gra
Recalled May 18, 2016 · FDA recall Z-1644-2016 · Biomerieux
Hazard
Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin. · FDA Class I
Units
2,570 kits
Sold at
Foreign distribution in the countries of Czech Republic, Hong Kong (China), Hungary, Japan, Poland, South Africa, Switzerland, and Turkey.
Description
Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.
Product
Vitek 2 Gram Positive Susceptibility Test Cards (AST-P643 REF 418671), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed in the Product Information manual.
Manufacturer(s)
Biomerieux Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →