Device product
Blood/MacConkey Biplate 100/PK, Product Number R02049
Z-2226-2025
Product summary
- Firm
- Remel, Inc
- Event
- Event 97224
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 611 untis
- Official record key
device-enforcement:Z-2226-2025
Official wording
Reason: The products may contain surface and subsurface contamination of Listeria monocytogenes.
Code information: UDI-DI: 848838003684; Lot Numbers: 274194
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Microbial contamination
contamination of Listeria monocytogenes