Recall Z-2874-2018— Biomerieux Inc

Class II · Terminated

Class II FDA medical device recall by Biomerieux Inc, initiated 2018-01-23, terminated 2021-07-13. FDA's recall record names no specific 510(k) clearance for this event. Product: bioM¿rieux VITEK 2 NH ID Test Kit Product Usage: Is an automated system consisting of instruments, software and reagent cards designed for the ID and antimicrobial susceptibility testing of bacteria and yeast.. Reason: Missing desiccant..

Recalling firm
Biomerieux Inc
Classification
Class II
Status
Terminated
Initiated
2018-01-23
Terminated
2021-07-13
Firm location
Hazelwood, MO, United States

Product description

bioM¿rieux VITEK 2 NH ID Test Kit Product Usage: Is an automated system consisting of instruments, software and reagent cards designed for the ID and antimicrobial susceptibility testing of bacteria and yeast.

Reason for recall

Missing desiccant.

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