LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894L
Summary
The FDA issued a Class II for LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894L by Microbiologics Inc. 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 impact.
Details
Source
Device Recall
External ID
Z-2195-2025
Action Date
2025-08-06
Status
Ongoing
Category
device
Product Description
LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894L
Lot/Code Info: 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.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-06-27
Company
Saint Cloud, MN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 157 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Microbiologics Inc has 52 FDA actions in our database, including 52 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Microbiologics Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Microbiologics Inc have FDA actions?
Microbiologics Inc has 52 FDA actions in our database, including 52 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2195-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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