Blood MacConkey biplates may carry Listeria monocytogenes surface contamination
Blood/MacConkey Biplates, product number R02049, are being recalled because the products may contain surface and subsurface contamination of Listeria monocytogenes. 611 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
Blood/MacConkey Biplate, 100 per pack, product number R02049, UDI-DI 848838003684, is being recalled. The action covers 611 units from lot 274194.
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 plates are 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
- Blood/MacConkey Biplate 100/PK, Product Number R02049
- 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: 848838003684
- Lot Numbers: 274194
Distribution
Distributed nationwide across the United States.
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