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.
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: 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.
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