The Recall Desk
ModerateFDA (Devices)·Z-2168-2018·Announced 2018-06-20

BioMérieux Recalls VITEK 2 Gram Negative Susceptibility Cards Due to Temperature Excursion

BioMérieux is recalling VITEK 2 Gram Negative Susceptibility Cards shipped to Guadeloupe that experienced a temperature excursion exceeding acceptable limits.

What this means for you

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, but the source text does not report any illnesses, injuries, or adverse health consequences. The hazard is a potential loss of product efficacy due to temperature exposure, which fits the criteria for a moderate risk or precautionary recall.

Plain-English summary

BioMérieux SA is recalling 135 units (78 boxes) of VITEK 2 Gram Negative Susceptibility Cards (Ref: 413117, Lot Number 6330343103). The product is an in vitro test used in clinical laboratories to determine the susceptibility of aerobic gram-negative bacilli to antimicrobial agents.

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, BioMérieux's Global Supply Chain QA team asked the local distributor to place the products in quarantine in July 2017. However, the distributor informed BioMérieux in November 2017 that the products had already been delivered to customers.

The affected products were distributed internationally, specifically to customers in Guadeloupe. Clinical laboratories and healthcare facilities that received these specific lots should stop using the cards and contact BioMérieux for further instructions or replacement.

The recalled product

Product
The VITEK 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant aerobic gram negative bacilli to antimicrobial agents. Fully automated short-term
Manufacturer
BioMerieux SA
Category
Medical Device — In Vitro Diagnostics
Hazard

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 AST-N233 (ref: 413117): Lot Number 6330343103

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.

See all 9 products in this recall →

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Same hazard · temperature excursion

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