VIDAS LH diagnostic test substrate error causes delayed results
bioMerieux VIDAS LH test kits (lot 1008848600) are affected by a substrate error that prevents test execution, requiring users to repeat testing and potentially delaying results.
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 classification. The substrate error is a functional defect that prevents test execution rather than causing direct patient harm. No illnesses or injuries reported; the issue is preventable through repeat testing.
Plain-English summary
bioMerieux, Inc. is recalling one lot of VIDAS LH diagnostic test kits (REF 30406-01, lot 1008848600, UDI 03573026156930) due to a substrate error that prevents the test from running.
The substrate defect causes test failures and requires users to repeat the test, leading to potential delays in obtaining patient test results.
The affected lot was distributed nationwide across the United States. Healthcare facilities and laboratories using affected kits should identify and segregate the recalled lot and retest samples using unaffected product.
No injuries or illnesses have been reported. Facilities with questions should contact bioMerieux directly.
The recalled product
- Product
- VIDAS LH, REF 30406-01
- 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 03573026156930
- Lot #: 1008848600
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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