LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894L

FDA device recall Z-2195-2025 · posted 2025-07-29 · Open, Classified

Recall details

Recalling firm

Microbiologics Inc

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.

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

JTR

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.

Date initiated

2025-06-27

Date posted

2025-07-29

Location

Saint Cloud, MN