BioMérieux Recalls VITEK 2 Gram-Positive Cards Due to Temperature Excursion
BioMérieux is recalling VITEK 2 Gram-Positive identification cards in Guadeloupe because a shipment experienced a temperature excursion exceeding acceptable limits.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a moderate severity. The hazard involves a temperature excursion that may compromise product integrity, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
BioMérieux SA is recalling 15 boxes of VITEK 2 Gram-Positive identification cards (GP) (Lot Number 2420352403). These single-use disposable cards are intended for use with VITEK 2 Systems for the automated identification of Gram-positive organisms.
The recall was initiated because a shipment to Guadeloupe suffered a temperature excursion up to 47.8°C, which exceeded the acceptable limits for the product. After the issue was detected, Global Supply Chain QA asked the bioMérieux distributor in Guadeloupe to place the products in quarantine in July 2017. However, the distributor informed the company in November 2017 that the products had already been delivered to customers.
The affected products were distributed internationally, specifically to customers in Guadeloupe. Users should stop using the affected lot and contact BioMérieux for further instructions.
The recalled product
- 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…
- Manufacturer
- BioMerieux SA
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- VITEK¿ 2 GP (ref: 21342):Lot Number 2420352403
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 9 recalled by BioMerieux SA under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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