VIDAS Lyme IgM II Diagnostic Test Kits Recalled for Substrate Error
bioMerieux is recalling three lots of VIDAS Lyme IgM II diagnostic test kits due to a substrate error that prevents the test from running, requiring users to conduct another test to obtain 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: This is an FDA Class II medical device recall for a substrate defect that prevents test execution rather than producing incorrect results. With no evidence of misdiagnosis or patient harm, and the defect being immediately apparent to users, this precautionary recall meets the criteria for Moderate severity.
Plain-English summary
bioMerieux, Inc. is recalling three lots of VIDAS Lyme IgM II (LYM) diagnostic test kits (Lot numbers 1008636750, 1008768920, 1008857410) due to a substrate error discovered in the test kits.
A substrate error in the affected kits prevents the test from being completed. When this error occurs, users cannot complete the test and must conduct another test to obtain results, creating a delay in test turnaround time.
The affected test kits were distributed nationwide throughout the United States. Healthcare providers, laboratories, and other users with test kits from the affected lot numbers should stop using these kits and contact bioMerieux for instructions on replacement kits and further guidance.
The recalled product
- Product
- VIDAS Lyme IgM II (LYM), REF 416436
- Manufacturer
- bioMerieux, Inc.
- Hazard
- substrate-defect
- test-failure
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 (4)
- UDI 03573026447151
- Lot #: 1008636750
- 1008768920
- 1008857410
Distribution
Distributed nationwide across the United States.
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