Device product
remel BLOOD AGAR MacCONKEY AGAR BIPLATE, REF R02049, QTY 100, for invitro diagnostic use
Z-1200-2025
Product summary
- Firm
- Remel, Inc
- Event
- Event 96312
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 787 units
- Official record key
device-enforcement:Z-1200-2025
Official wording
Reason: Product may contain surface and subsurface contamination of Listeria monocytogenes which is typically visible immediately upon removal from the packaging, appearing on the blood side of the biplate.
Code information: UDI/DI 848838003691, Lot Number 213926, exp. 2025-02-24
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Microbial contamination
contamination of Listeria monocytogenes