LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894K (6-pack), 2) REF 0894P (2...
FDA Recall #Z-2194-2025 — Class II — June 27, 2025
Product Description
LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894K (6-pack), 2) REF 0894P (2-pack)
Reason for Recall
KWIK-STIK REF numbers: 0894P, 0894K and LYFO DISK" 0894L may result in failure to recover the target microorganism. All lots of REF 894-76 are impacted.
Recalling Firm
Microbiologics Inc — Saint Cloud, MN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
32 units
Distribution
Worldwide distribution - US Nationwide and the countries of France, Colombia, Philippines, Peru, Turkey, India, Finland, Trinidad and Tobago, Poland, Viet Nam, Brazil, Japan, Malaysia, Costa Rica.
Code Information
1) 0894K: UDI/DI 30845357021954, Lot Numbers: 894-76-81; 2) 0894P: UDI/DI 20845357021940, Lot Numbers: 894-76-21, 894-76-51, 894-76-52.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated