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.
Reported: April 15, 2015 Initiated: February 25, 2015 #Z-1401-2015
Product Description
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.
Reason for Recall
The outer carton label and package insert for the recalled product incorrectly lists Streptococcus pneumoniae as an organism for intended use.
Details
- Recalling Firm
- Biomerieux Inc
- Units Affected
- 10409 cartons
- Distribution
- Worldwide Distribution to United Kingdom and Turkey. NO U.S. distribution.
- Location
- Hazelwood, MO
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Biomerieux Inc. Units affected: 10409 cartons.
Why was this product recalled? ▼
The outer carton label and package insert for the recalled product incorrectly lists Streptococcus pneumoniae as an organism for intended use.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 15, 2015. Severity: Low. Recall number: Z-1401-2015.
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