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.
What this means for you
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
- Hazard
- diagnostic-failure
- storage-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/DI 03573026065850
- Batch Numbers: 1009371140
Distribution
Distributed nationwide across the United States.
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