The Recall Desk
ModerateFDA (Devices)·Z-2166-2018·Announced 2018-06-20

BioMerieux VITEK 2 ANC Card Recalled Due to Temperature Excursion

BioMerieux is recalling VITEK 2 ANC identification 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. The hazard is a temperature excursion that may compromise product integrity, but no specific injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

BioMerieux SA is recalling 135 units (78 boxes) of the VITEK 2 Anaerobic and Corynebacteria identification card (ANC). The recall involves Lot Number 2440318203 (ref: 21347). The product is a single-use disposable device intended for use with VITEK 2 Systems for the automated identification of anaerobic organisms and Corynebacterium species.

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 requested that the bioMerieux distributor in Guadeloupe 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 check their inventory for the specific lot number and reference number listed above. If the product matches the recalled lot, it should be removed from use and returned to the distributor or manufacturer according to their instructions.

The recalled product

Product
The VITEK¿ 2 Anaerobic and Corynebacteria identification card (ANC) is intended for use with the VITEK¿ 2 Systems for the automated identification of most clinically significant anaerobic organisms and Corynebatcerium species. The VITEK¿ 2 ANC identification card is a single-use
Manufacturer
BioMerieux SA
Category
Medical Device — In Vitro 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 ANC (ref: 21347): Lot Number 2440318203

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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