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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 March 25, 2013
Create Date February 14, 2022
Recall Status1 Terminated 3 on April 22, 2022
Recall Number Z-0641-2022
Recall Event ID 89479
510(K)Number K861022  
Product Classification Kit, quality control for culture media - Product Code JTR
Product KWIK-STIK(TM), Quality control kit for culture media, sold as:

KWIK-STIK(TM) 2-pack Enterococcus faecalis derived from ATCC(R) 51299(TM)
Code Information Catalog Number 01023P, UDI: 20845357029502, Lot Number (Expiration Date): 1023-05-7 (04/30/2014)
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		 Some of the KWIK-STIK Catalog #01023P Campylobacter coli, Lot# 1023-05-7, contained an inner label stating the product is Catalog #0919K Haemophilus influenza. The organism has been confirmed to be C. coli, indicating this is a labeling error and the organism is the correct organism.
FDA Determined
Cause 2		 Labeling mix-ups
Action Microbiologics notified customers on 03/25/2013 via letter titled "Important Medical Device Correction". Instructions included to inspect inventory for affected products. If customers have received the product identified within the recall (KWIK-STIK" 01023P, Lot# 1023-05-7), it is recommended that the customer destroys the product. Microbiologics shall replace the destroyed product upon confirmation of destruction. Questions or concerns can be directed to the Customer Service Manager at 320.229.7057.
Quantity in Commerce 10 units
Distribution Worldwide distribution - US Nationwide and the countries of Canada, South Africa, France, Netherlands, Mauritius, China.
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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