API 20 C AUX Diagnostic Strips Recalled Due to Storage Temperature Exceedance
Biomerieux Inc is recalling API 20 C AUX diagnostic strips due to storage conditions that exceeded temperature and time specifications. The manufacturer cannot guarantee 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 recall with no reported illnesses or injuries. The hazard is theoretical—the product's performance cannot be guaranteed due to storage condition exceedance, but no actual product failures or harm have been reported.
Plain-English summary
Biomerieux Inc is recalling API 20 C AUX 25 STRIPS+25 MEDIA (Catalog 20210) because storage conditions exceeded temperature and time specifications. The affected batch number is 1009373680.
During storage or handling, temperature and time parameters exceeded the product's specifications. As a result, the manufacturer cannot guarantee the product's performance.
The product was distributed nationwide in the United States. No illnesses or injuries associated with this recall have been reported.
The recalled product
- Product
- API 20 C AUX 25 STRIPS+25 MEDIA, CATALOG 20210
- Manufacturer
- Biomerieux Inc
- Category
- Medical Device
- 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 03573026048082
- Batch Number 1009373680
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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