Recall Z-2195-2025 ยท JTR Kit, Quality Control For Culture Media
Microbiologics Inc
LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894L
| Date | Jul 29, 2025 (initiated Jun 27, 2025) |
| Status | Open, Classified |
| 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. |
| Root cause | Under Investigation by firm |
| Action | 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 distri |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.