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U.S. Department of Health and Human Services

Class 2 Device Recall KWIKSTIK

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  Class 2 Device Recall KWIKSTIK see related information
Date Initiated by Firm October 08, 2020
Create Date November 05, 2020
Recall Status1 Terminated 3 on November 03, 2022
Recall Number Z-0402-2021
Recall Event ID 86574
510(K)Number K861022  
Product Classification Kit, quality control for culture media - Product Code JTR
Product Catalog 02145P, Klebsiella pneumoniae derived from NCTC 13439 - Product Usage: intended to be used as controls to verify the performance of assays, reagents or media that are intended to be used in microbial testing for the detection and identification of a cultured microorganism isolate.
Code Information Catalog 01245P; Lots 1245-03-1, 1245-03-2, 1245-03-3, 1245-03-4, 1245-04-1  UDI: 20845357040446
Recalling Firm/
Manufacturer		 Microbiologics Inc
200 Cooper Ave N
Saint Cloud MN 56303-4440
For Additional Information Contact Emily Dunaisky
320-229-7073
Manufacturer Reason
for Recall		 Strain should be VIM-1 positive but is confirmed to be VIM-1 negative.
FDA Determined
Cause 2		 Under Investigation by firm
Action Communication was extended to consignees that received product directly from the recalling firm. Distributors outside of the United States will be contacted via email, and if follow-up is required, the recalling firm's international sales team will contact the distributor to ensure that this communication is extended to their end-users. The recalling firm will work with the European Authorized Representative to coordinate all field safety corrective actions for consignees in the EU. The recalling firm will conduct effectiveness checks by contacting 100% of consignees that do not respond to the correspondence. This will be completed via phone or email.
Quantity in Commerce 46 units
Distribution Worldwide distribution - US Nationwide distribution and the countries of Austria, Canada, Chile, China, Germany, India, Ireland, Japan, Philippines, United Kingdom, and Vietnam.
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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