Biomerieux VIDAS Estradiol II Test Systems Recalled for Storage Condition Exceedance
Biomerieux Inc is recalling VIDAS Estradiol II 60 Tests (Catalog 30431-01, Batch 1009378680) distributed nationwide after temperature and time storage conditions were exceeded, potentially compromising test reliability.
What this means for you
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 with no reported injuries or illnesses. The hazard is precautionary—products were improperly stored but no actual test failures or patient harm have been documented.
Plain-English summary
Biomerieux Inc is recalling VIDAS Estradiol II 60 Tests (Catalog 30431-01) in response to storage condition violations. The affected units (Batch 1009378680) experienced temperature and time excursions beyond specified limits during distribution.
As a result of these storage condition exceedances, the performance of the affected test systems cannot be guaranteed. The recalled products were distributed nationwide to clinical laboratories and healthcare facilities.
Healthcare providers and laboratory professionals who may have received units from the affected batch should contact Biomerieux Inc for guidance on the proper disposition of the affected products. Users should verify their lot numbers against the recall notice and follow the manufacturer's instructions regarding the recalled items.
The recalled product
- Product
- VIDAS CLINICAL VIDAS ESTRADIOL II 60 TESTS, CATALOG 30431-01
- Manufacturer
- Biomerieux Inc
- Affected units
- 7
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 03573026161637
- Batch Numbers: 1009378680
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.
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