The Recall Desk
HighFDA (Devices)·Z-1200-2025·Announced 2025-02-26

Medical Diagnostic Culture Media Recalled for Listeria Contamination

Remel, Inc recalls blood agar culture media used in diagnostic laboratories for potential Listeria monocytogenes contamination. The affected lot was distributed nationwide.

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: High-risk pathogen Listeria monocytogenes is explicitly identified in contamination of medical diagnostic product. However, no illnesses or injuries are reported, and the contamination is reportedly visible, allowing for detection.

Plain-English summary

Remel, Inc is recalling its BLOOD AGAR MacCONKEY AGAR BIPLATE (REF R02049, lot 213926) due to potential surface and subsurface contamination with Listeria monocytogenes. A total of 787 units were distributed nationwide.

The contamination is typically visible immediately upon removal from the packaging, appearing on the blood side of the biplate. This contamination may compromise the reliability of diagnostic test results using these culture plates.

Laboratories that have received this product should stop using the affected lot and contact Remel, Inc for return instructions. Healthcare providers relying on test results from this media should review any recent diagnostic work performed with the affected lot.

The recalled product

Product
remel BLOOD AGAR MacCONKEY AGAR BIPLATE, REF R02049, QTY 100, for invitro diagnostic use
Manufacturer
Remel, Inc
Category
Medical Device — Diagnostic Culture Media
Hazard
  • listeria
  • contamination

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 (3)

  • UDI/DI 848838003691
  • Lot Number 213926
  • exp. 2025-02-24

Distribution

Distributed nationwide across the United States.

Related recalls

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