Remel Blood Agar Plates Recalled for Listeria Contamination
Remel Inc is recalling Blood Agar plates due to confirmed surface contamination with Listeria monocytogenes. The products were distributed nationwide and in Puerto Rico.
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) with a confirmed complaint of contamination, but no reported illnesses or injuries are mentioned in the source text, fitting the criteria for a High severity score.
Plain-English summary
Remel Inc is recalling Blood Agar (TSA w/ 5% Sheep Blood) Plates, intended for in vitro diagnostic use, because of a confirmed complaint of surface contamination with Listeria monocytogenes. The affected product is manufactured by Remel Inc in Lenexa, KS, and is used for the cultivation of microorganisms and visualization of hemolytic reactions.
The recall covers 1,159 packs of 100 plates each. These products were distributed nationwide in the states of Arkansas, Arizona, Colorado, Iowa, Illinois, Kansas, Kentucky, Louisiana, Michigan, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Mexico, Ohio, Oklahoma, South Dakota, and Texas, as well as Puerto Rico. The specific code for the affected product is 101686.
Consumers and healthcare facilities should stop using the recalled Blood Agar plates immediately. Users should check their inventory for the specific product code and contact Remel Inc for further instructions or a refund if they have purchased or received these items.
The recalled product
- Product
- Blood Agar (TSA w/ 5% Sheep Blood) Plate, For In Vitro Diagnostic Use, Remel, Lenexa, KS 66215 Product Usage: Blood Agar is a solid medium recommended for use in qualitative procedures for the cultivation of a wide variety of microorganisms and visualization of hemolytic…
- 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)
- 101686
Distribution
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