LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894L
- Company
- Microbiologics Inc
- Recall Initiated
- June 27, 2025
- Posted
- July 29, 2025
- Recall Number
- Z-2195-2025
- Firm Location
- Saint Cloud, MN
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.
Lot / Code Info
1) 0894L: UDI/DI 10845357021967, Lot Numbers 894-76-4 and 894-76-6
Root Cause
Under Investigation by firm
Action Taken
Microbiologics issued an Urgent Medical Device Recall notice on 06/27/2025 via email. The notice explained the problem with the device, potential risk, and requested the following: INSTRUCTIONS: 1. REVIEW lab procedures to understand how this information affects your usage. 2. USE OR DISCARD depending on your lab procedures and how this information affects your usage. 3. COMPLETE the response form provided. 4. RETURN the response form to recall@microbiologics.com. 5. KEEP this letter for your records. 6. NOTIFY other facilities or customers to whom the product may have been distributed or transferred. 7. CONTACT Microbiologics if a replacement kit is needed. Contact Recall Support team at 320.229.7080 or recall@microbiologics.com with questions or concerns.