Vitek 2 Gram Positive Susceptibility Test Cards (AST-P640 REF 418579), 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.

Reason: Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.

Code information: Lots 740340920 exp. 4/14/16, 740350820 exp. 7/22/16, 740356320 exp. 9/15/16, 740361110 exp. 11/2/16, 740371720 exp. 2/16/17, 740386420 exp. 7/13/17, and 740388520 exp. 8/3/17.

Distribution pattern: Foreign distribution in the countries of Czech Republic, Hong Kong (China), Hungary, Japan, Poland, South Africa, Switzerland, and Turkey.