Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0438-2022·Announced 2022-01-05

VIDAS SARS-CoV-2 IgM Diagnostic Test Recalled for Substrate Error

bioMerieux is recalling one lot of VIDAS SARS-CoV-2 IgM tests nationwide due to a substrate defect that prevents the test from running. The defect causes delayed results as users must repeat testing.

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 a Class II medical device recall with no reported illnesses, hospitalizations, or injuries. The hazard is operational—a substrate defect that prevents test execution—rather than a direct patient safety threat. The precautionary and operational nature of this recall aligns with Score 2 (Moderate) per the rubric.

Plain-English summary

bioMerieux, Inc. is recalling one lot (Lot #1008710950) of VIDAS SARS-CoV-2 IgM diagnostic tests distributed nationwide. The recall involves UDI 03573026620738 for product Ref 423833-01.

The recall is prompted by an increasing number of complaints related to a substrate error in this lot. The defect prevents the test from being run, making it impossible to complete the diagnostic procedure. Users experiencing this error must run another test to obtain results, causing potential delays in patient diagnosis.

Healthcare providers and laboratory facilities using this lot should discontinue testing with affected units and contact bioMerieux, Inc. for replacement tests and further guidance.

The recalled product

Product: VIDAS SARS-COV-2 IgM, Ref 423833-01
Manufacturer: bioMerieux, Inc.
Category: Medical Device — Serological 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 (2)

UDI 03573026620738
Lot #: 1008710950

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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