The Recall Desk
ModerateFDA (Devices)·Z-2165-2018·Announced 2018-06-20

BioMérieux Recalls VITEK 2 NH Cards Due to Temperature Excursion

BioMérieux is recalling VITEK 2 Neisseria-Haemophilus identification cards in Guadeloupe that were exposed to temperatures 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 hospitalizations. The hazard is a potential loss of product efficacy due to temperature exposure, which aligns with the 'Moderate' criteria for low-risk contamination or voluntary precautionary measures without reported harm.

Plain-English summary

BioMérieux SA is recalling VITEK 2 Neisseria-Haemophilus identification cards (NH) due to a temperature excursion. The affected product is a single-use disposable microorganism differentiation and identification device intended for use with VITEK 2 Systems to identify clinically significant fastidious organisms.

A shipment of 2 boxes of NH TEST KIT with 20 Cards (Lot Number 2450355203) destined for Guadeloupe was exposed to temperatures up to 47.8°C, which exceeded the acceptable limits for the product. Following the detection of this issue in July 2017, BioMérieux’s Global Supply Chain QA team requested that the local distributor place the products in quarantine. However, the distributor reported in November 2017 that the products had already been delivered to customers.

Healthcare facilities and customers in Guadeloupe who possess this specific lot of VITEK 2 NH cards should stop using them and contact BioMérieux for further instructions. The recall is limited to the specific lot number and distribution area mentioned in the notice.

The recalled product

Product
The VITEK 2 Neisseria-Haemophilus identification card (NH) is intended for use with the VITEK 2 Systems for the automated identification of most clinically significant fastidious organisms. The VITEK 2 NH identification card is a single-use disposable. A microorganism differe
Manufacturer
BioMerieux SA
Category
Medical Device — Laboratory Diagnostic
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 NH (ref: 21346): Lot Number 2450355203

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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