Z-2195-2025Class II

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

Name: Z-2195-2025 LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894L
Creator: Microbiologics Inc
Published: 2025-06-27
License: https://open.fda.gov/license/

Microbiologics, Inc. / initiated 2025-06-27 / Open, Classified

FDA source

Microbiologics Inc began a recall of LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894L on 2025-06-27. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2195-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-06-27
Posted: 2025-07-29
Recalling firm: Microbiologics, Inc.
Product: LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894L
Product code: JTR Kit, Quality Control For Culture Media
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 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 [email protected]. 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 [email protected] with questions or concerns.
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.
Product codes and lots: 1) 0894L: UDI/DI 10845357021967, Lot Numbers 894-76-4 and 894-76-6

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2195-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2194-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-08-06	2025-07-29
Z-2195-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-08-06	2025-07-29

Product code JTR

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)