Strep Selective II Agar plates may carry Listeria monocytogenes contamination
Strep Selective II Agar, product number R01859, is being recalled because the products may contain surface and subsurface contamination of Listeria monocytogenes. 371 units are affected.
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: Risk-of-harm product: culture media that may itself carry Listeria monocytogenes, with no infection reported in the source.
Plain-English summary
Strep Selective II Agar, product number R01859, UDI-DI 848838003158, is being recalled. The action covers 371 units from lot 271613.
The stated reason is that the products may contain surface and subsurface contamination of Listeria monocytogenes. The FDA classified the action as Class II. The source does not report any infection having occurred.
Distribution was nationwide in the United States. The agar is supplied to laboratories rather than sold to consumers.
Laboratories should identify affected stock using the product number, UDI-DI and lot number above and follow the instructions issued by the manufacturer.
The recalled product
- Product
- Strep Selective II Agar, Product Number R01859
- Manufacturer
- Remel, Inc
- Category
- Medical Device — Culture media
- Hazard
- listeria-monocytogenes
- media-contamination
- microbiology
- class-ii
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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