Agency classClass IIOur severity:High FDA (Devices)·Z-0797-2023·Announced 2023-01-11

Biomerieux VIDAS RUB IGG Tests Recalled Due to Storage Conditions

Biomerieux is recalling VIDAS RUB IGG diagnostic tests nationwide after storage temperature and duration exceeded specifications, affecting product performance guarantees.

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 recall of a diagnostic test product where performance cannot be guaranteed due to storage condition failure. This qualifies as a risk-of-harm product, as inaccurate test results could affect clinical decision-making, with no reported illnesses or injuries to date.

Plain-English summary

Biomerieux Inc is recalling VIDAS RUB IGG diagnostic test kits nationwide. The recall involves Batch Number 1009370850 (UDI/DI 03573026138585) distributed across the United States.

The recall was initiated because the affected product exceeded the specified storage temperature and time parameters. When storage conditions are not maintained as required, product performances cannot be guaranteed.

Healthcare facilities and laboratories that received this product should verify batch numbers and contact Biomerieux Inc for guidance on potentially affected units.

The recalled product

Product: VIDAS CLINICAL VIDAS RUB IGG 60 TESTS, CATALOG 30226
Manufacturer: Biomerieux Inc
Category: Medical Device — Clinical Laboratory Diagnostics
Hazard: performance-degradation
inaccurate-results
Affected units: 2

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/DI 03573026138585
Batch Numbers: 1009370850

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 94 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 94 products in this recall →

Same manufacturer · Biomerieux Inc

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