Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0436-2022·Announced 2022-01-05

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.

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: 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.
Category: Medical Device — In Vitro Diagnostic Test
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.

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 →

Same manufacturer · bioMerieux, Inc.

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