The Recall Desk
ModerateFDA (Devices)·Z-2169-2018·Announced 2018-06-20

BioMérieux Recalls VIDAS TOXO IgG Avidity Test Due to Temperature Excursion

BioMérieux is recalling VIDAS TOXO IgG Avidity tests because a shipment to Guadeloupe exceeded temperature limits. The products were delivered to customers despite quarantine instructions.

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 test accuracy, but the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

BioMérieux SA is recalling 2 boxes of VIDAS TOXO IgG Avidity tests (Lot Number 1005621420). This automated qualitative test is used to determine anti-toxoplasma IgG avidity in human serum or plasma. The recall is limited to products distributed internationally, specifically those shipped to Guadeloupe.

The recall was initiated because a shipment to Guadeloupe experienced temperature excursions 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 bioMérieux 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.

Healthcare facilities and customers in Guadeloupe who possess this specific lot of VIDAS TOXO IgG Avidity tests should stop using them and contact BioMérieux for instructions on return or disposal. The source text does not report any illnesses or injuries associated with this recall.

The recalled product

Product
VIDAS TOXO IgG Avidity is an automated qualitative test for use on the VIDAS family instruments, for the determination of anti-toxoplasma IgG avidity in human serum or plasma (lithium heparin, sodium citrate, EDTA) using the ELFA technique (Enzyme Linked Fluorescent Assay). T
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)

  • VIDAS¿ TOXO IgG AVIDITY (ref: 30222): Lot Number 1005621420

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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