Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
The VITEK 2 Gram-Positive identification card (GP) is intended for Recalled by BioMerieux SA Due to A shipment to Guadeloupe suffered a temperature excursions...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact BioMerieux SA directly.
Affected Products
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.
Quantity: 15 boxes with GP TEST KIT VTK2 20 CARDS
Why Was This 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.
Where Was This Sold?
International distribution.
About BioMerieux SA
BioMerieux SA has 45 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report