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

• Date Initiated by Firm: June 05, 2006
• Date Posted: April 03, 2007
• Recall Status: Terminated 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/ Manufacturer: 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: Other
• 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.