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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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).…
- Manufacturer
- BioMerieux SA
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 →Related recalls
Same manufacturer · BioMerieux SA
See all →- HighMYLA Diagnostic System Software Versions Recalled for Risk of False Negatives
FDA (Devices) · 2021-10-20
- HighMYLA Laboratory Software: Potential Test Result Alteration from Software Anomaly
FDA (Devices) · 2021-08-18
- ModerateBioMerieux NucliSENS Magnetic Extraction Reagents Recalled Due to Temperature Exposure
FDA (Devices) · 2018-10-31
- ModerateBioMerieux Recalls VIDAS FSH Assay Kits Due to Calibration Issues
FDA (Devices) · 2018-07-04
- ModerateBioMérieux Recalls VITEK 2 Gram-Positive Cards Due to Temperature Excursion
FDA (Devices) · 2018-06-20
Same hazard · temperature excursion
See all →- ModerateCyclophosphamide injection vials recalled after a transportation temperature excursion
FDA (Drugs) · 2025-09-24
- ModerateXolair 75 mg syringes exposed to temperatures outside labeled storage requirements
FDA (Drugs) · 2025-08-13
- ModerateRecombinate antihemophilic factor vials exposed to temperatures outside labeled storage
FDA (Drugs) · 2025-08-13
- ModerateXolair auto-injectors exposed to temperatures outside labeled storage requirements
FDA (Drugs) · 2025-08-13
- ModerateProlia prefilled syringes recalled after potential temperature excursions during transit delays
FDA (Drugs) · 2025-07-30
Similar recalls
- HighMeasles Antibody Test Kits Recalled Due to Temperature Excursion
FDA (Devices) · 2023-01-11
- HighBiomerieux VIDAS RUB IGG Tests Recalled Due to Storage Conditions
FDA (Devices) · 2023-01-11
- ModerateDiagnostic test kit recalled due to substrate error preventing test execution
FDA (Devices) · 2022-01-05
- HighVIDAS Varicel Zoster IGG 60T Recalled Due to Storage Condition Excursion
FDA (Devices) · 2023-01-11
- HighbioMerieux Recalls VIDAS Varicella Zoster IgG Antibody Test Kits
FDA (Devices) · 2020-02-19
- HighBiomerieux Recalls VIDAS LH 60 Clinical Tests for Temperature-Induced Performance Issues
FDA (Devices) · 2023-01-11