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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 February 24, 2021
Date Posted January 28, 2022
Recall Status1 Terminated 3 on July 11, 2022
Recall Number Z-0543-2022
Recall Event ID 89379
510(K)Number K861022  
Product Classification Kit, quality control for culture media - Product Code JTR
Product KWIK-STIK, Candida parapsilosis derived from ATCC 22019, REF 0726P. Packaged 2 units per pack. IVD controls.
Code Information Catalog Number: 0726P, Lot Number: 726-57-10, UDI: 20845357017486
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		 Potential that products packaged for lot 726-57-10 were packaged in pouches labeled as 323-108-7.
FDA Determined
Cause 2		 Labeling mix-ups
Action Microbiologics notified customers on about 02/24/2021 via letter titled "Urgent Medical Device Recall." Instructions included to inspect inventory for affected products. If found, instructions were to: 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. CONTACT Microbiologics if a replacement kit is needed. Questions or concerns can be directed to Recall Support team at 320.229.7073 or recall@microbiologics.com.
Quantity in Commerce 65 packs (130 units)
Distribution Worldwide distribution - US distribution in the states of GA, MS, MT, NC, NM, NV, TN, TX, WA, WI and the countries of Brazil, Canada, China, Colombia, Dominican Republic, France, India, Ireland, Japan, Mexico, Oman, Philippines, Romania, South Africa, Turkey, United Arab Emirates.
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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