Strep Selective II Agar Recalled for Listeria Contamination
Remel, Inc. is recalling Strep Selective II Agar (371 units) due to potential surface and subsurface contamination with Listeria monocytogenes. Users should contact the manufacturer for instructions.
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: This is an FDA Class II medical device recall involving Listeria monocytogenes, a high-risk pathogen explicitly cited in the severity rubric. No illnesses or injuries have been reported, placing this at the high-risk-pathogen-without-reported-illness threshold of score 3.
Plain-English summary
Remel, Inc. is recalling Strep Selective II Agar, Product Number R01859 (371 units, nationwide distribution). The product is a laboratory culture medium used in clinical microbiology testing.
The recalled product may contain surface and subsurface contamination with Listeria monocytogenes, a pathogenic bacterium. This contamination could compromise the integrity of laboratory test results and pose potential risks to laboratory personnel who handle the material.
The affected lot is 271613 (UDI-DI: 848838003158). The product was distributed nationwide. Laboratories and other users should verify their inventory by checking the lot number against their received shipments.
Users who have received the affected product should contact Remel, Inc. immediately for instructions on product return, replacement, or proper disposal.
The recalled product
- Product
- Strep Selective II Agar, Product Number R01859
- Manufacturer
- Remel, Inc
- 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 (2)
- UDI-DI: 848838003158
- Lot Numbers: 271613
Distribution
Distributed nationwide across the United States.
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