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
Product summary
- 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
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.