VIDAS Lyme diagnostic test device recalled due to substrate error
bioMerieux recalled VIDAS Lyme IgG II test devices (two lots) due to a substrate error that prevents tests from running. Users must retest patients, potentially delaying Lyme disease diagnosis.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II recall of a diagnostic device. Although no illnesses or injuries have been reported, the substrate error prevents test execution and creates a risk of harm through potential diagnostic delays for a serious disease.
Plain-English summary
bioMerieux, Inc. is recalling two lots of VIDAS Lyme IgG II diagnostic test devices (REF 417401). The affected lots are 1008714880 and 1008824220. The product was distributed nationwide in the United States.
A substrate error prevents the test from running properly. When the error occurs, users cannot obtain test results and must run the test again. This can delay diagnosis of Lyme disease.
Healthcare facilities and laboratories using the affected lots should discontinue use and contact bioMerieux for replacement units or guidance. Patients with pending test results should consult their healthcare provider about the delay.
The recalled product
- Product
- VIDAS Lyme IgG II (LYM), REF 417401
- 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 (3)
- UDI 03573026458270
- Lot #: 1008714880
- 1008824220
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
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