Recall Z-2165-2018— 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 Neisseria-Haemophilus identification card (NH) is intended for use with the VITEK 2 Systems for the automated identification of most clinically significant fastidious organisms. The VITEK 2 NH identification card is a single-use disposable. A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.. 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.