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U.S. Department of Health and Human Services

Class 2 Device Recall KWIKSTIK and LYFO DISK

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  Class 2 Device Recall KWIKSTIK and LYFO DISK see related information
Date Initiated by Firm December 16, 2020
Create Date January 19, 2022
Recall Status1 Terminated 3 on July 07, 2022
Recall Number Z-0511-2022
Recall Event ID 89285
510(K)Number K861022  
Product Classification Kit, quality control for culture media - Product Code JTR
Product KWIK-STIK 2 Pack, Catalog #0894P; KWIK-STIK 6 Pack, Catalog #0894K; and LYFO DISK, Catalog #0894L; Microsporum canis derived from ATCC 36299.
Code Information KWIK-STIK 2 Pack - Catalog#: 0894P, Lot #: 894-68-3, Exp. 6/30/2022, 894-68-4, Exp. 6/30/2022, UDI: 20845357022947;  KWIK-STIK 6 Pack - Catalog#: 0894K, Lot #: 894-68-1, Exp. 6/30/2022, UDI: 30845357022951;  LYFO DISK - Catalog#: 0894L, Lot #: 894-68-2, Exp. 6/30/2022, UDI: 10845357022964; 
Recalling Firm/
Manufacturer		 Microbiologics Inc
200 Cooper Ave N
Saint Cloud MN 56303-4440
For Additional Information Contact Becky Neu
320-229-7073
Manufacturer Reason
for Recall		 Contamination with S. epidermidis
FDA Determined
Cause 2		 Material/Component Contamination
Action The recalling firm issued letters beginning 12/16/2020 to their consignees explaining the reason for recall and that due to the distinct morphology of Microsporum canis, it is possible to distinguish between the 2 colonies and select the correct microorganism from an agar plate for testing. The consignee was provided the instructions to review their lab procedures to understand how this information affects their usage, use or discard depending on their lab procedures and how this information affects their usage, complete the response form and return it to the firm. The letter is to kept for their records and the firm is to be contacted for a replacement kit if needed. The response form was to indicate the consignee has acknowledged receipt of the information, has updated their records, and to report the number of kits on hand. If the consignee has discarded or destroyed individual units, they are to indicate the quantity needed for replacement.
Quantity in Commerce 59 kits
Distribution Distribution was made to CA, IA, IL, LA, MA, MI, NY, PA, SD, TN, VA, WI, and WV. There was no government/military distribution. Foreign distribution was made to Brazil, Canada, Colombia, Dominican Republic, Finland, France, India, Japan, Malaysia, Mexico, Netherlands, Poland, Romania, Saudi Arabia, Serbia, South Africa, and United Kingdom.
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.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JTR and Original Applicant = MICRO-BIO-LOGICS
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