Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0432-2022·Announced 2022-01-05

VIDAS RUB IgG Diagnostic Test Kit Recalled for Substrate Defect

bioMerieux is recalling three lots of VIDAS RUB IgG test kits due to substrate errors that prevent the test from running, potentially delaying diagnostic 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 recall of a medical device with an operational defect. No illnesses or injuries have been reported, and the hazard is functional rather than a direct safety threat. The substrate error causes test failure requiring re-testing, which primarily impacts diagnostic timing rather than patient safety.

Plain-English summary

bioMerieux, Inc., is recalling three lots of VIDAS RUB IgG (RBG), REF 30226 diagnostic test kits due to a substrate error affecting the test cartridges. The defect prevents the test from running properly, which means affected tests cannot complete and users must run another test to obtain results.

The recall affects three specific lot numbers: 1008694980, 1008700260, and 1008828980. These products were distributed nationwide throughout the United States.

No illnesses or injuries have been reported in connection with this recall. The primary concern is operational—the substrate error causes test failures that result in delayed diagnostic results.

Facilities currently using affected VIDAS RUB IgG test kits should stop use of the identified lot numbers and contact bioMerieux for replacement products or further guidance.

The recalled product

Product: VIDAS RUB IgG (RBG), REF 30226
Manufacturer: bioMerieux, Inc.
Category: Medical Device — Diagnostic Test Kit
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 03573026138585
Lot #: 1008694980
1008700260
1008828980

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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