VIDAS HCG 60 Clinical Test Kits Recalled for Exceeded Storage Conditions
Biomerieux Inc is recalling VIDAS HCG 60 test kits because storage conditions were exceeded, which cannot guarantee product performance. No illnesses or injuries have been reported.
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 a Class II FDA medical device recall initiated due to exceeded storage conditions that prevent the manufacturer from guaranteeing product performance. With no reported illnesses or injuries and the hazard being precautionary in nature, this meets the criteria for a voluntary precautionary recall.
Plain-English summary
Biomerieux Inc is recalling VIDAS CLINICAL VIDAS HCG 60 TESTS (Catalog 30405-01, Batch 1009527770) distributed nationwide in the United States. The recall was initiated because storage temperature and time parameters were exceeded.
Because storage conditions were not maintained within specifications, the manufacturer cannot guarantee product performance. For a diagnostic test kit, users cannot rely with certainty on the accuracy of results from these devices.
No illnesses or injuries have been reported to the FDA. Consumers who have these test kits should contact Biomerieux Inc or the FDA for guidance.
The recalled product
- Product
- VIDAS CLINICAL VIDAS HCG 60 TESTS, CATALOG 30405-01
- Manufacturer
- Biomerieux Inc
- Affected units
- 4
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 03573026156923
- Batch Numbers: 1009527770
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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