Agency classClass IIOur severity:High FDA (Devices)·Z-0439-2022·Announced 2022-01-05

VIDAS SARS-COV-2 Diagnostic Test Recalled for Substrate Error

bioMerieux is recalling two lots of VIDAS SARS-COV-2 IgG diagnostic tests due to substrate errors that prevent test execution, requiring users to repeat testing and potentially delaying 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 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: FDA Class II diagnostic device with substrate errors that prevent test execution. No reported illnesses, injuries, or deaths. Score 3 (High) applies as a risk-of-harm product where injury has not been reported; diagnostic test malfunction poses risk of delayed or missed diagnosis.

Plain-English summary

bioMerieux, Inc. is recalling two lots of VIDAS SARS-COV-2 IgG diagnostic tests (Lot numbers 1008671430 and 1008763910). This in vitro diagnostic device detects IgG antibodies to SARS-COV-2 and was distributed nationwide throughout the United States.

The product has been found to have substrate errors that prevent the test from being executed. When this error occurs, users cannot obtain results from the affected sample and must run another test, potentially delaying diagnosis.

bioMerieux has been receiving an increasing number of complaints related to this substrate error. Users with affected lots should be aware of this issue and monitor for substrate errors during testing.

The recalled product

Product: VIDAS SARS-COV-2 IgG, Ref 423834-01
Manufacturer: bioMerieux, Inc.
Category: Medical Device — In Vitro Diagnostic Test
Hazard: substrate-error
test-failure
delayed-results

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 03573026620745
Lot #: 1008671430
1008763910

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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Same hazard · substrate error