Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0433-2022·Announced 2022-01-05

VIDAS LH diagnostic test substrate error causes delayed results

bioMerieux VIDAS LH test kits (lot 1008848600) are affected by a substrate error that prevents 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 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: FDA Class II classification. The substrate error is a functional defect that prevents test execution rather than causing direct patient harm. No illnesses or injuries reported; the issue is preventable through repeat testing.

Plain-English summary

bioMerieux, Inc. is recalling one lot of VIDAS LH diagnostic test kits (REF 30406-01, lot 1008848600, UDI 03573026156930) due to a substrate error that prevents the test from running.

The substrate defect causes test failures and requires users to repeat the test, leading to potential delays in obtaining patient test results.

The affected lot was distributed nationwide across the United States. Healthcare facilities and laboratories using affected kits should identify and segregate the recalled lot and retest samples using unaffected product.

No injuries or illnesses have been reported. Facilities with questions should contact bioMerieux directly.

The recalled product

Product: VIDAS LH, REF 30406-01
Manufacturer: bioMerieux, Inc.
Category: Medical Device — Diagnostic Test Kit
Hazard: substrate-error
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 03573026156930
Lot #: 1008848600

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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