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U.S. Department of Health and Human Services

Class 3 Device Recall KWIKSTIK"

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  Class 3 Device Recall KWIKSTIK" see related information
Date Initiated by Firm May 06, 2022
Create Date May 23, 2022
Recall Status1 Terminated 3 on January 16, 2024
Recall Number Z-1125-2022
Recall Event ID 90150
510(K)Number K861022  
Product Classification Kit, quality control for culture media - Product Code JTR
Product KWIK-STIK" plus: Clostridium perfringens
Code Information catalog number: 0801P; lot number: 801-44-4; expiration date: 05/31/2023; UDI: 20845357019374
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		 Labeling error.
FDA Determined
Cause 2		 Labeling mix-ups
Action The firm issued a recall notification to the consignees beginning on 05/06/2022 via email. The letter informs the consignee to inspect inventory, review lab procedures, use or discard affected product depending on lab procedures, and complete the response form.
Quantity in Commerce 8 units
Distribution Distributed US Nationwide to IA, TN and internationally to Mexico, Colombia, France, South Africa, 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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