API VP1 VP2 Medical Reagents Recalled for Storage Condition Failure
Biomerieux Inc is recalling API VP1 VP2 reagents (Catalog 70422) nationwide because storage temperature and time limits were exceeded, preventing the manufacturer from guaranteeing 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 medical device recall in which reagent performance cannot be guaranteed due to storage condition violations. This is a risk-of-harm product where no injury has been reported to date, placing it at the High severity level per the rubric.
Plain-English summary
Biomerieux Inc is recalling API VP1 VP2 REAGENTS (Catalog 70422) because the product was stored outside the specified temperature and time ranges. The storage condition violations prevent the manufacturer from guaranteeing product performance.
The affected batch number is 1009393450 (UDI/DI 03573026099626). The product was distributed nationwide in the United States.
Customers who have received this product should discontinue use and contact Biomerieux Inc for replacement or return instructions. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- API VP1 VP2 REAGENTS, CATALOG 70422
- Manufacturer
- Biomerieux Inc
- Hazard
- storage-condition-failure
- product-performance-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 03573026099626
- Batch Numbers: 1009393450
Distribution
Distributed nationwide across the United States.
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