Vitek 2 Gram Positive Susceptibility Test Cards (AST-P644 REF 418673), 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.
Reported: May 18, 2016 Initiated: February 24, 2016 #Z-1645-2016
Product Description
Vitek 2 Gram Positive Susceptibility Test Cards (AST-P644 REF 418673), 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 for Recall
Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.
Details
- Recalling Firm
- Biomerieux Inc
- Units Affected
- 5,575 kits
- Distribution
- Foreign distribution in the countries of Czech Republic, Hong Kong (China), Hungary, Japan, Poland, South Africa, Switzerland, and Turkey.
- Location
- Hazelwood, MO
Frequently Asked Questions
What product was recalled? ▼
Vitek 2 Gram Positive Susceptibility Test Cards (AST-P644 REF 418673), 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.. Recalled by Biomerieux Inc. Units affected: 5,575 kits.
Why was this product recalled? ▼
Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 18, 2016. Severity: Critical. Recall number: Z-1645-2016.
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