Reported May 18, 2016 · Terminated

Vitek 2 Gram Positive Susceptibility Test Cards (AST-P642 REF 418604), 20 cards/kit. Product Usage: The VITEK 2 Gram…

Biomerieux Inc.

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Biomerieux Inc · 595 Anglum Rd · Hazelwood, MO · 63042-2320

Vitek 2 Gram Positive Susceptibility Test Cards (AST-P642 REF 418604), 20 cards/kit
Product UsageThe 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

Lot codes and dates: Lots 742343610 exp. 5/11/16
742347220 exp. 6/16/16
742350010 exp. 7/14/16
742352820 exp. 8/11/16
742355710 exp. 9/9/16
742362540 exp. 11/16/16
742364020 exp. 12/1/16
742368210 exp. 1/12/16
742376540 exp. 4/5/17
742383610 exp. 6/15/17
and 742389220 exp. 8/10/17
Amount recalled: 15,006 kits

The agency filed one notice per product. You are reading one of them; the other 8 are below.

Stop using this product now

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

Using this product could cause serious injury, illness or death — stop using it now.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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27 in total.