remel Blood Agar EMB Agar Biplate Recalled for Listeria Contamination
Remel's blood agar culture media plates (lot 213971) may contain Listeria monocytogenes contamination visible on the blood side. The affected product was distributed nationwide; users should discontinue use immediately.
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: FDA Class II recall for Listeria monocytogenes contamination, a high-risk pathogen explicitly listed in the severity rubric. No illnesses or injuries have been reported, placing this at the 'High' severity tier per rubric criteria for high-risk pathogens without reported illness.
Plain-English summary
Remel, Inc. is recalling remel BLOOD AGAR EMB AGAR BIPLATE (diagnostic culture media), lot number 213971 with expiration date February 25, 2025. The product may contain surface and subsurface contamination of Listeria monocytogenes, which is typically visible on the blood side of the biplate when removed from packaging.
316 units of the affected lot were distributed nationwide. The product is used by healthcare facilities and clinical laboratories for diagnostic culture and testing purposes.
Users should discontinue use of the affected lot immediately. Facilities that have used or may have used the contaminated product should review their diagnostic testing processes and contact Remel, Inc. for guidance on product return and next steps.
The recalled product
- Product
- remel BLOOD AGAR EMB AGAR BIPLATE, REF R02041, QTY 100, for invitro diagnostic use
- Manufacturer
- Remel, Inc
- Hazard
- Affected units
- 316
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 848838003684
- Lot Number 213971
- exp. 2025-02-25
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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