Z-0986-2026 Class II Ongoing
FDA device recall Z-0986-2026 was initiated by Microbiologics Inc on December 2, 2025 and is designated Class II. Reason for recall: Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428. The recall status is ongoing. Affected quantity: 1 unit (16 additional units added 12/22/25).
Recall Details
- Product Type
- Devices
- Report Date
- December 31, 2025
- Initiation Date
- December 2, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 unit (16 additional units added 12/22/25)
Product Description
LYFO DISK, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325L
Reason for Recall
Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.
Distribution Pattern
Worldwide - US Nationwide.
Code Information
UDI-DI: 10845357006476; Lot Numbers: 325-120-5, Additional lots added 12/22/25: 325-119-3, 325-119-6