The Recall Desk
HighFDA (Devices)·Z-0783-2023·Announced 2023-01-11

Listeria Detection Test Strips Recalled for Unreliable Performance

Biomerieux is recalling API Listeria detection test strips that were exposed to temperature and time exceedance during storage. Product performance cannot be guaranteed as a result.

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 a Class II FDA recall involving Listeria, a high-risk pathogen. Although no illnesses or injuries have been reported, the risk of detection failure could result in serious harm. This matches the rubric criterion for High severity: 'high-risk pathogens (Listeria...) without reported illness.'

Plain-English summary

Biomerieux Inc. is recalling API LISTERIA 10 STRIPS+10 MEDIA, Catalog 10300, Batch Number 1009418280, distributed nationwide in the United States.

The affected test strips were exposed to temperature and time conditions exceeding specified storage parameters during distribution. The manufacturer has stated that product performance cannot be guaranteed as a result of these storage exceedances.

The recall applies to all units bearing batch number 1009418280. Laboratories and facilities in possession of this batch should discontinue use immediately.

For information on replacement units or further guidance, contact Biomerieux Inc. directly.

The recalled product

Product
API LISTERIA 10 STRIPS+10 MEDIA, CATALOG 10300
Manufacturer
Biomerieux Inc
Category
Medical Device — Diagnostic Test Strip
Hazard
  • listeria
  • improper-storage
  • performance-degradation

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 03573026035587
  • Batch Number 1009418280

Distribution

Distributed nationwide across the United States.

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