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U.S. Department of Health and Human Services

Class 3 Device Recall DiaSorin 1,25Dihydroxyvitamin D RIA Kit

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  Class 3 Device Recall DiaSorin 1,25Dihydroxyvitamin D RIA Kit see related information
Date Initiated by Firm June 05, 2006
Date Posted April 03, 2007
Recall Status1 Terminated 3 on June 25, 2007
Recall Number Z-0707-2007
Recall Event ID 37632
510(K)Number K014030  
Product Classification 1,25-Dihydroxyvitamin D RIA Kit - Product Code MRG
Product 1,25-Dihydroxyvitamin D RIA Kit -For the quantitative determination of 1,25 Dihydroxyvitamin D in serum or EDTA plasma-DiaSorin, Stillwater, Minnesota 55082-0285, USA
Code Information Catalog #65100E. Kit Lot #''s 117139, 117140, 1117141
Recalling Firm/
Diasorin Inc.
1951 Northwestern Ave S
Stillwater MN 55082-7536
Manufacturer Reason
for Recall
Potential for the DiaSorin Kit 1,25-Dihydroxyvitamin D RIA Kit Control 1 (lot 548520) & 2 (lot 548521) to recover out of the defined range, LOW. (If one or both of the kit controls recover outside the defined range, the run is considered invalid)
FDA Determined
Cause 2
Action Product recalled by letter dated 6/01/2006
Quantity in Commerce 715
Distribution Worldwide Distribution-USA including states of UT, CO, IL, NY, NV, MI, NC, MN, VA, GA, CA, KS, VT, CT and IN, and Countries of Canada, Sweden, Germany, Belgium, Italy, France, Norway, Australia, South Korea, Taiwan, Israel, New Foundland, India, China, Brazil, Austria, Saudi Arabia, and Spain
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 = MRG and Original Applicant = DIASORIN, INC.