Class 3 Device Recall DiaSorin GammaCoat Androstenedione 125I RIA Kit

• Date Initiated by Firm: July 15, 2004
• Date Posted: March 18, 2005
• Recall Status: Terminated on July 22, 2006
• Recall Number: Z-0634-05
• Recall Event ID: 30937
• 510(K)Number: K854650
• Product Classification: Radioimmunoassay, Androstenedione - Product Code CIZ
• Product: DiaSorin GammaCoat Androstenedione - [125I] RIA Kit Catalog No. CA-1725, DiaSorin Stillwater, Minnesota 55082-0285, U.S.A. Lot # 05144. for the quantitative determination of androstenedione levels in serum.
• Code Information: Catalog No. CA 1725, Lot # 05144
• Recalling Firm/ Manufacturer: Diasorin Inc.; 1951 Northwestern Ave S; Stillwater MN 55082-7536
• For Additional Information Contact: DiaSorin Technical Service; 800-328-1482
• Manufacturer Reason for Recall: Standards used in the GammaCoat Androstenedione Radioimmunoassay Kit appeared yellowish in color and were gelatinous upon reconstitution.
• FDA Determined Cause: Other
• Action: Customers were sent a customer notification letter identifying the product and the problem and requesting a response identifying the number of replacement kits needed.
• Quantity in Commerce: 163 Kits (lot 05144) 95 Kits (06114B)
• Distribution: MN, MA, KY, Saudi Arabia, Jordan, Sweden, Germany, Spain, Belgium, Italy, Canada, Australia, Portugal, Hungary, Switzerland & Israel
• 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 = CIZ