FDA recall Z-2194-2025

Microbiologics Inc · Class II · device

Product

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.

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.

Key facts

Status
Ongoing
Initiation date
2025-06-27
Report date
2025-08-06
Voluntary/Mandated
Voluntary: Firm initiated
Location
Saint Cloud, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2194-2025