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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 Disksee related information
Date Initiated by FirmJuly 17, 2015
Create DateMarch 16, 2022
Recall Status1 Completed
Recall NumberZ-0788-2022
Recall Event ID 89513
510(K)NumberK861022 
Product Classification Kit, quality control for culture media - Product Code JTR
ProductLYFO Disk
Code Information Catalog Number 0983L, UDI: 10845357023930, Lot Number (Expiration Date): 983-40-3 (02/11/2016)
FEI Number 2150138
Recalling Firm/
Manufacturer		 Microbiologics Inc
200 Cooper Ave N
Saint Cloud MN 56303-4440
For Additional Information ContactTina 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
ActionMicrobiologics 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 Commerce3 units
DistributionDistribution is nationwide with three consignees located in Colorado, Georgia, and Ohio.
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.
510(K) Database510(K)s with Product Code = JTR
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