The Recall Desk
HighFDA (Devices)·Z-0784-2023·Announced 2023-01-11

Biomerieux API 20 E 25 Strips Recalled for Storage Condition Failure

Biomerieux Inc is recalling API 20 E 25 Strips (Batch 1009226560) because temperature and time excursions during storage exceeded specified parameters. Product performance cannot be guaranteed.

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: This is an FDA Class II medical device recall where product performance cannot be guaranteed due to storage condition excursions. Although no illnesses or injuries have been reported, the risk of device failure or inaccurate results exists, fitting the criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Biomerieux Inc is recalling API 20 E 25 STRIPS, CATALOG 20100 (UDI/DI 03573026047818, Batch Number 1009226560) that was distributed nationwide in the United States.

The recall was initiated after the manufacturer identified that product units were exposed to temperature and time conditions outside the specified storage parameters. Because of these conditions, the manufacturer cannot guarantee that the product will perform to its intended specifications.

Users of this product should contact Biomerieux Inc for further guidance. The recall specifically affects Batch Number 1009226560.

The recalled product

Product
API 20 E 25 STRIPS, CATALOG 20100
Manufacturer
Biomerieux Inc
Category
Medical Device
Hazard
  • performance-degradation
  • storage-excursion

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 03573026047818
  • Batch Number 1009226560

Distribution

Distributed nationwide across the United States.

Related recalls

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