Diagnostic test kit recalled due to substrate error preventing test execution
A diagnostic test kit manufactured by bioMerieux has been recalled because a substrate error prevents the test from running, which delays test results for patients.
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: FDA Class II recall with no reported illnesses or injuries. The hazard is a device malfunction that prevents test execution, causing operational delays rather than direct patient harm.
Plain-English summary
bioMerieux has recalled one lot of the VIDAS TOXO IgG Avidity (TXGA) diagnostic test kit. Lot #1008861590 (UDI 03573026263010) contains a substrate error that prevents the test from running properly.
When affected units fail to run, laboratory staff must discard the test and run a new one, which delays the generation of test results. bioMerieux has reported receiving an increasing number of complaints related to this substrate error.
The recalled lot was distributed nationwide. Laboratories should check their inventory for lot #1008861590 and discontinue use. Contact bioMerieux for replacement units or further guidance.
The recalled product
- Product
- VIDAS TOXO IgG Avidity (TXGA), REF 30222-01
- Manufacturer
- bioMerieux, Inc.
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 (2)
- UDI 03573026263010
- Lot #: 1008861590
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 16 recalled by bioMerieux, Inc. 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 16 products in this recall →Related recalls
Same manufacturer · bioMerieux, Inc.
See all →- HighBiomerieux VITEK 2 AST-N461 Test Kit Recalled for Card Pouch Damage
FDA (Devices) · 2026-09-30
- HighVITEK 2 AST-N447 Test Kit Potentially Returns False Resistant Results
FDA (Devices) · 2026-07-15
- HighSusceptibility test cards recalled over false resistant antibiotic results
FDA (Devices) · 2026-02-11
- HighAntimicrobial susceptibility test cards recalled over false colistin resistance results
FDA (Devices) · 2025-10-08
- SevereVITEK 2 AST Test Kits: Ceftriaxone Concentration Error Risk
FDA (Devices) · 2024-05-01
Same hazard · device malfunction
See all →- ModerateMedtronic NDI Passive Spheres Recalled for Reflective Material Variation
FDA (Devices) · 2026-10-28
- SevereVentec VC+Pro Ventilator Recalled for Potential Connector Disconnection
FDA (Devices) · 2026-10-28
- ModerateMedtronic InterStim Percutaneous Extensions Recalled for Incompatible Lead Selection
FDA (Devices) · 2026-10-28
- SevereVentec Ventilator Cable Recall Due to Potential Disconnection
FDA (Devices) · 2026-10-28
- ModerateMedtronic InterStim SureScan MRI Leads Recalled for Incompatible Selection
FDA (Devices) · 2026-10-28
Similar recalls
- HighBiomerieux VIDAS RUB IGG Tests Recalled Due to Storage Conditions
FDA (Devices) · 2023-01-11
- HighbioMerieux Recalls VIDAS Varicella Zoster IgG Antibody Test Kits
FDA (Devices) · 2020-02-19
- HighVIDAS Listeria 60T Clinical Diagnostic Test Kit Recalled for Storage Failure
FDA (Devices) · 2023-01-11
- ModerateDiagnostic Test Kit Recalled Due to Exceeded Storage Conditions
FDA (Devices) · 2023-01-11
- ModerateBioMérieux Recalls VIDAS TOXO IgG Avidity Test Due to Temperature Excursion
FDA (Devices) · 2018-06-20
- ModerateBiomerieux VIDAS Estradiol II Test Systems Recalled for Storage Condition Exceedance
FDA (Devices) · 2023-01-11