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.
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 3/5 (High).
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
- Affected units
- 1
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.
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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