Blood agar plates may carry Listeria monocytogenes surface contamination
Blood Agar with 5% Sheep Blood, product number R01202, is being recalled because the products may contain surface and subsurface contamination of Listeria monocytogenes. 1,552 units 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 Agar, 5% Sheep Blood, 100 per pack, product number R01202, UDI-DI 848838000645, is being recalled. The action covers 1,552 units from lots 271595 and 271596.
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 numbers above and follow the instructions issued by the manufacturer.
The recalled product
- Product
- Blood Agar,5% Sheep Blood 100/PK, Product Number R01202
- Manufacturer
- Remel, Inc
- Category
- Medical Device — Culture media
- Affected units
- 1,552
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 (3)
- UDI-DI: 848838000645
- Lot Numbers: 271595
- 271596
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Remel, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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