The Recall Desk
HighFDA (Devices)·Z-0785-2023·Announced 2023-01-11

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.

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 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
Hazard
  • improper-storage
  • performance-defect

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.

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