BioMerieux SA recalls The VITEK 2 Gram-Positive identification card (GP) is intended for use with the VITEK 2 Systems for the automated ident…

Recall date

March 23, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2164-2018

FDA classification

Class II

Brand / firm

BioMerieux SA

Sold / distributed

International distribution.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

The VITEK 2 Gram-Positive identification card (GP) is intended for use with the VITEK 2 Systems for the automated identification of most significant Gram-positive organisms. The VITEK 2 GP identification card Is a single-use disposable. GP TEST KIT VTK2 20 CARTES 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.