Biomerieux Inc recalls Vitek 2 Gram Positive Susceptibility Test Cards (AST-P639 REF 418662), 20 cards/kit. Product Usage: The VITEK 2 Gram Po…

Recall date

February 24, 2016

Source

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

Recall number

Z-1640-2016

FDA classification

Class I

Brand / firm

Biomerieux Inc

Sold / distributed

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

Why it was recalled

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

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Vitek 2 Gram Positive Susceptibility Test Cards (AST-P639 REF 418662), 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.