Device product
OXOID MICROBACT IDENTIFICATION KITS, Listeria 12L Kit, 20 Tests; Listeria identification sysystem
Z-1766-2026
Product summary
- Event
- Event 98539
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2 kits
- Official record key
device-enforcement:Z-1766-2026
Official wording
Reason: Oxoid Ltd., part of Thermo Fisher Scientific, confirmed that Microbact 12L Kit 20 Tests MB1128A lot 4494873 may identify incorrect organism due to inconclusive result from ambiguous color reactions in wells.
Code information: UDI/DI 5032384127498, Lot Number 4494873
Distribution pattern: US Nationwide distribution in the states of GA and CA.
Derived failure modes
-
Unknown
Oxoid Ltd., part of Thermo Fisher Scientific, confirmed that Microbact 12L Kit 20 Tests MB1128A lot 4494873 may identify incorrect organism due to inconclusive result from ambiguous color reactions in wells.