FDA-Device2025-12-31Class IIPROCESSING DEFECT
Microbiologics LYFO DISK Campylobacter jejuni recalled for potential recovery failure
What this means
Microbiologics Inc. is recalling certain LYFO DISK products containing Campylobacter jejuni subsp. jejuni (Catalog Number 0325L) because affected units may fail to recover the target microorganism as intended. This affects laboratory testing and quality control processes.
- Check if you have LYFO DISK Catalog Number 0325L in lot numbers 325-120-5, 325-119-3, or 325-119-6
- Contact Microbiologics Inc. for instructions on replacement or refund
- Do not use affected units for culture recovery or testing
The agency's original wording
Hazard
Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.
Intended for
All ages
Illnesses reported
None reported
Sold states
Worldwide - US Nationwide.
Affected count
1 unit (16 additional units added 12/22/25)
Manufactured in
200 Cooper Ave N, N/A, Saint Cloud, MN, United States
Products
LYFO DISK, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325L
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0986-2026Want us to check the next one for you?
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