Reported Apr 15, 2015 · Terminated
Vitek 2 AST-P635 REF 416 911 Gram Positive Susceptibility Card, 20 cards per container, IVD. Intended for use with the…
Biomerieux Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.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
Is this the product you have?
- 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.
- Lot codes and dates
9 of 9 products
Products covered by this recall # Product as published 1 lot 735352820, expiration 11AUG16 2 lot 735348620, expiration 30JUN16 3 lot 735346520, expiration 09JUN16 4 lot 735342320 5 expiration 28APR16 6 lot 735318020, expiration 29AUG15 7 lot 735315920, expiration 08AUG15 8 lot 735323710, expiration 25OCT15 9 lot 735310210, expiration 12JUN15 - Amount recalled
- 10409 cartons
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Why it was recalled
The outer carton label and package insert for the recalled product incorrectly lists Streptococcus pneumoniae as an organism for intended use.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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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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