Remel Blood Agar Plates Recalled for Listeria monocytogenes Contamination
Remel Inc is recalling specific lots of Blood Agar plates due to potential Listeria monocytogenes contamination. The products were 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: The recall involves a high-risk pathogen (Listeria monocytogenes) without reported illness, which corresponds to a score of 3 (High) per the rubric.
Plain-English summary
Remel Inc is voluntarily recalling specific lots of Remel Blood Agar (TSA w/sheep blood) plates, reference number R01202. The recall involves 845 cases, with each case containing 100 plates. The affected lot numbers are 646595 and 646596, and the expiration date for these products is May 19, 2015.
The recall is being issued because the product may be contaminated with Listeria monocytogenes. Blood agar is a solid medium used in qualitative procedures for cultivating microorganisms and visualizing hemolytic reactions. The affected products were distributed nationwide.
Consumers and healthcare facilities should check their inventory for the specific lot numbers and expiration dates listed above. If the products are found, they should be removed from use and returned to the supplier or disposed of according to local regulations.
The recalled product
- Product
- Remel Blood Agar (TSA w/sheep blood) plate REF R01202 packaged 10 plates per pack, 10/10-packs per case (100 plates). Blood agar is a solid medium recommended for use in qualitative procedures for the cultivation of a wide variety of microorganisms and visualization of…
- Manufacturer
- Remel Inc
- Hazard
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 (1)
- Lot Number: 646595 and 646596 Expiration date: 19May2015
Distribution
Distributed nationwide across the United States.
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