Biomerieux VIDAS Progesterone Tests Recalled for Storage Condition Failure
Biomerieux is recalling VIDAS Progesterone 60 diagnostic tests (Batch 1009375960) nationwide due to storage temperature and time conditions being exceeded, preventing guaranteed product performance.
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 recall for a diagnostic device where storage conditions were exceeded and product performance cannot be guaranteed. No illnesses or injuries have been reported, but this qualifies as a risk-of-harm product—a diagnostic test that may not perform reliably could affect clinical decision-making and patient care.
Plain-English summary
Biomerieux Inc is recalling VIDAS Clinical VIDAS Progesterone 60 Tests (Catalog 30409-01) distributed nationwide. The affected product includes 6 units with Batch Number 1009375960 and UDI/DI 03573026156954.
The recall was issued because storage and handling conditions exceeded specified temperature and time parameters. When these conditions are exceeded, the manufacturer cannot guarantee product performance. VIDAS Progesterone is an in vitro diagnostic test used to measure progesterone levels in clinical settings.
According to FDA, this is a Class II recall. The exceeded storage conditions prevent assurance of the test's reliability and clinical accuracy.
The recalled product
- Product
- VIDAS CLINICAL VIDAS PROGESTERONE 60 TESTS, CATALOG 30409-01
- Manufacturer
- Biomerieux Inc
- Category
- Medical Device — Diagnostic Test
- Hazard
- storage-condition-failure
- product-performance-degradation
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 03573026156954
- Batch Numbers: 1009375960
Distribution
Distributed nationwide across the United States.
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