Recall Z-2167-2018— BioMerieux SA

Class II FDA medical device recall by BioMerieux SA, initiated 2018-03-23, terminated 2020-06-23. FDA's recall record names no specific 510(k) clearance for this event. Product: The VITEK¿ 2 Gram Positive Susceptibility Card is 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 to antimicrobial agents. Fully automated short-term incubation cycle antimicrobial susceptibility system is a device that incorporates concentrations of antimicrobial agents into a system for the purpose of determining in vitro susceptibility of bacterial pathogens isolated from clinical specimens. Test results obtained from short-term (less than 16 hours) incubation are used to determine the antimicrobial agent of choice to treat bacterial diseases.. Reason: A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable limits. After detection of the issue, Global Supply Chain QA asked the bioM¿rieux distributor in Guadeloupe to put products in quarantine in July 2017; After several reminders, the distributor informed in November 2017 that products were delivered to customers..

Recalling firm

BioMerieux SA

Classification

Class II

Status

Terminated

Initiated

2018-03-23

Terminated

2020-06-23

Firm location

Marcy L'Etoile, N/A, France

Data sourced from openFDA. This site is unofficial and independent of the FDA.