Device product
LYFO DISK, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325L
Z-0986-2026
Product summary
- Event
- Event 98079
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1 unit (16 additional units added 12/22/25)
- Official record key
device-enforcement:Z-0986-2026
Official wording
Reason: Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.
Code information: UDI-DI: 10845357006476; Lot Numbers: 325-120-5, Additional lots added 12/22/25: 325-119-3, 325-119-6
Distribution pattern: Worldwide - US Nationwide.
Derived failure modes
-
Unknown
Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.