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BioMerieux SA recalls The VITEK 2 Gram-Positive identification card (GP) is intended for use with the VITEK 2 Systems for the automated identi
Recalled June 20, 2018 · FDA recall Z-2164-2018 · BioMerieux SA
Hazard
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. · FDA Class II
Units
15 boxes with GP TEST KIT VTK2 20 CARDS
Sold at
International distribution.
Description
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.
Product
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.
Manufacturer(s)
BioMerieux SA
Made in
France
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →