FDA Enforcement
Class II
Ongoing
OXOID MICROBACT IDENTIFICATION KITS, Listeria 12L Kit, 20 Tests; Listeria identification sysystem
Recall: Z-1766-2026
·
Reported April 8, 2026
Enforcement
- Recall Number
- Z-1766-2026
- Event ID
- 98539
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Oxoid Australia Pty Limited
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 8, 2026
- Initiation Date
- March 3, 2026
- Classification Date
- April 2, 2026
- Address
- 20 Dlgleish St, South Australia, N/A, Australia
Description
OXOID MICROBACT IDENTIFICATION KITS, Listeria 12L Kit, 20 Tests; Listeria identification sysystem
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 Info
UDI/DI 5032384127498, Lot Number 4494873
Distribution
US Nationwide distribution in the states of GA and CA.
Quantity
2 kits