Agency classClass IIOur severity:High FDA (Devices)·Z-0798-2023·Announced 2023-01-11

VIDAS Listeria 60T Clinical Diagnostic Test Kit Recalled for Storage Failure

Biomerieux recalls VIDAS Listeria 60T test kits (Batch 1009371140) distributed nationwide because storage conditions were exceeded and product performance cannot be guaranteed. Users should discontinue use and contact the manufacturer.

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 medical device recall involving a diagnostic test where storage failure means product performance cannot be guaranteed. No hospitalization or illness reports documented in the source. Score reflects risk-of-harm from potential diagnostic failure rather than reported adverse events.

Plain-English summary

The VIDAS Listeria 60T (Catalog 30700) is a clinical diagnostic test kit manufactured by Biomerieux Inc. The company is recalling 10 units nationwide (Batch 1009371140, UDI/DI 03573026065850) because the product was exposed to storage temperature and time conditions that exceeded acceptable limits.

When storage conditions fall outside specifications, the reliability of diagnostic test results cannot be guaranteed. This is particularly important for a Listeria diagnostic test used in clinical settings, where accurate results are critical for patient diagnosis and treatment decisions.

Healthcare facilities and clinical laboratories that received this batch should discontinue use of the affected units and contact Biomerieux Inc or their distributor for replacement or proper disposal of the recalled items.

The recalled product

Product: VIDAS CLINICAL VIDAS LISTERIA 60T, CATALOG 30700
Manufacturer: Biomerieux Inc
Category: Medical Device — Clinical Diagnostic Test Kit
Hazard: diagnostic-failure
storage-failure
Affected units: 10

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 03573026065850
Batch Numbers: 1009371140

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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