The Recall Desk
ModerateFDA (Devices)·Z-2167-2018·Announced 2018-06-20

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

BioMérieux is recalling VITEK 2 Gram Positive Susceptibility Cards in Guadeloupe because a shipment experienced a temperature excursion up to 47.8°C, 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 involves a temperature excursion that may compromise the accuracy of the in vitro test results, but no specific injuries, illnesses, or deaths are reported in the source text.

Plain-English summary

BioMérieux SA is recalling 5 boxes of VITEK 2 Gram Positive Susceptibility Cards (Lot Number 4860117403) distributed in Guadeloupe. The product is an in vitro test used in clinical laboratories to determine the susceptibility of specific bacteria 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, 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.

Customers who possess this specific lot of VITEK 2 Gram Positive Susceptibility Cards should stop using them and contact BioMérieux for instructions on return or replacement.

The recalled product

Product
The VITEK¿ 2 Gram Positive Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents. Fully automated short
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 AST-P606 (ref: 22330): Lot Number 4860117403

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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