Recall Z-1403-2015— Biomerieux Inc
Class III · Terminated
Class III FDA medical device recall by Biomerieux Inc, initiated 2015-02-25, terminated 2017-03-22. FDA's recall record names no specific 510(k) clearance for this event. Product: Vitek 2 AST-P641 REF 418 590 Gram Positive Susceptibility Card, 20 cards per carton, 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: The outer carton label and package insert for the recalled product incorrectly lists Streptococcus pneumoniae as an organism for intended use..
- Recalling firm
- Biomerieux Inc
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2015-02-25
- Terminated
- 2017-03-22
- Firm location
- Hazelwood, MO, United States
Product description
Vitek 2 AST-P641 REF 418 590 Gram Positive Susceptibility Card, 20 cards per carton, 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.