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U.S. Department of Health and Human Services

Class 2 Device Recall Microbiologics LYFODISC

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 Class 2 Device Recall Microbiologics LYFODISCsee related information
Date Initiated by FirmJune 27, 2025
Date PostedJuly 29, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2195-2025
Recall Event ID 97168
Product Classification Kit, quality control for culture media - Product Code JTR
ProductLYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894L
Code Information 1) 0894L: UDI/DI 10845357021967, Lot Numbers 894-76-4 and 894-76-6
Recalling Firm/
Manufacturer		 Microbiologics Inc
200 Cooper Ave N
Saint Cloud MN 56303-4440
For Additional Information ContactRebecca Neu
320-229-7080
Manufacturer 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 2		Under Investigation by firm
ActionMicrobiologics 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.
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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