Recall Z-1639-2016— Biomerieux Inc
Class I · Terminated
Class I FDA medical device recall by Biomerieux Inc, initiated 2016-02-24, terminated 2018-03-08. FDA's recall record names no specific 510(k) clearance for this event. Product: Vitek 2 Gram Positive Susceptibility Test Cards (AST-P636 REF 417951), 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: Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin..
- Recalling firm
- Biomerieux Inc
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2016-02-24
- Terminated
- 2018-03-08
- Firm location
- Hazelwood, MO, United States
Product description
Vitek 2 Gram Positive Susceptibility Test Cards (AST-P636 REF 417951), 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.