Recall Z-2195-2025
Microbiologics Inc · initiated June 27, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894L
Codes / lots: 1) 0894L: UDI/DI 10845357021967, Lot Numbers 894-76-4 and 894-76-6
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.
FDA-determined 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.
Details
- Recall number
- Z-2195-2025
- Initiated
- June 27, 2025
- Posted by FDA
- July 29, 2025
- Product code
- JTR – Kit, Quality Control For Culture Media
- 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.
- Recalling firm
- Microbiologics Inc, Saint Cloud, MN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2194-2025 Class II | LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894K (6-pack), 2) REF…KWIK-STIK REF numbers: 0894P, 0894K and LYFO DISK" 0894L may result in failure to recover the target… | 06/27/2025Open, Classified |