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Recall Observatory FDA recall evidence

Device product

LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894K (6-pack), 2) REF 0894P (2-pack)

Z-2194-2025

June 27, 2025

Class II

Product summary

Firm
Microbiologics Inc
Event
Event 97168
Status
Ongoing
Classification
Class II
Quantity
32 units
Official record key
device-enforcement:Z-2194-2025

Official wording

Reason: 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.

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.

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.