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.
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: 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
- Hazard
- Affected units
- 787
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.
Part of a larger recall action
This product is one of 2 recalled by Remel, 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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