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U.S. Department of Health and Human Services

Class 3 Device Recall LYFO Disk

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  Class 3 Device Recall LYFO Disk see related information
Date Initiated by Firm July 17, 2015
Create Date March 16, 2022
Recall Status1 Completed
Recall Number Z-0788-2022
Recall Event ID 89513
510(K)Number K861022  
Product Classification Kit, quality control for culture media - Product Code JTR
Product LYFO Disk
Code Information Catalog Number 0983L, UDI: 10845357023930, Lot Number (Expiration Date): 983-40-3 (02/11/2016)
Recalling Firm/
Manufacturer		 Microbiologics Inc
200 Cooper Ave N
Saint Cloud MN 56303-4440
For Additional Information Contact Tina Sobania
320-310-9217
Manufacturer Reason
for Recall		 LYFO Disk Catalog #0983L is to contain Candida tropicalis. However, lot number 983-40-3 under Catalog #0983L, labeled as Candida tropicalis, is actually Yersinia entercolitica. This labeling error may cause a user's quality control to fail, resulting in testing needing to be repeated and delayed test results.
FDA Determined
Cause 2		 Labeling mix-ups
Action Microbiologics notified customers on 07/17/2015 via letter titled "Medical Device Recall". Instructions included to inspect inventory for affected products. If customers have received the product identified within the recall (LYFO DISK 0983L, Lot# 983-40-3), it is recommended that the customer destroys the product or return it to the recalling firm. Acknowledgement of the receipt of the recall letter was requested by completing a form and returning to Microbiologics. Questions or concerns can be directed to the Quality Systems Manager at 320.229.7050.
Quantity in Commerce 3 units
Distribution Distribution is nationwide with three consignees located in Colorado, Georgia, and Ohio.
Total Product Life Cycle TPLC 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.
510(K) Database 510(K)s with Product Code = JTR and Original Applicant = MICRO-BIO-LOGICS
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