Biomerieux VIDAS RUB IGG Tests Recalled Due to Storage Conditions
Biomerieux is recalling VIDAS RUB IGG diagnostic tests nationwide after storage temperature and duration exceeded specifications, affecting product performance guarantees.
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 of a diagnostic test product where performance cannot be guaranteed due to storage condition failure. This qualifies as a risk-of-harm product, as inaccurate test results could affect clinical decision-making, with no reported illnesses or injuries to date.
Plain-English summary
Biomerieux Inc is recalling VIDAS RUB IGG diagnostic test kits nationwide. The recall involves Batch Number 1009370850 (UDI/DI 03573026138585) distributed across the United States.
The recall was initiated because the affected product exceeded the specified storage temperature and time parameters. When storage conditions are not maintained as required, product performances cannot be guaranteed.
Healthcare facilities and laboratories that received this product should verify batch numbers and contact Biomerieux Inc for guidance on potentially affected units.
The recalled product
- Product
- VIDAS CLINICAL VIDAS RUB IGG 60 TESTS, CATALOG 30226
- Manufacturer
- Biomerieux Inc
- Hazard
- performance-degradation
- inaccurate-results
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 03573026138585
- Batch Numbers: 1009370850
Distribution
Distributed nationwide across the United States.
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