Blood EMB Levine plates may carry Listeria monocytogenes contamination
Blood/EMB Levine plates, product number R02041, are being recalled because the products may contain surface and subsurface contamination of Listeria monocytogenes. 750 units are affected.
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: Risk-of-harm product: culture media that may itself carry Listeria monocytogenes, with no infection reported in the source.
Plain-English summary
Blood/EMB, Levine, 100 per pack, product number R02041, UDI-DI 848838003684, is being recalled. The action covers 750 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/EMB, Levine 100/PK, Product Number R02041
- Manufacturer
- Remel, Inc
- Category
- Medical Device — Culture media
- Affected units
- 750
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.
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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