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U.S. Department of Health and Human Services

Class 3 Device Recall DiaSorin GammaCoat Androstenedione 125I RIA Kit

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  Class 3 Device Recall DiaSorin GammaCoat Androstenedione 125I RIA Kit see related information
Date Initiated by Firm July 15, 2004
Date Posted March 18, 2005
Recall Status1 Terminated 3 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/
Diasorin Inc.
1951 Northwestern Ave S
Stillwater MN 55082-7536
For Additional Information Contact DiaSorin Technical Service
Manufacturer Reason
for Recall
Standards used in the GammaCoat Androstenedione Radioimmunoassay Kit appeared yellowish in color and were gelatinous upon reconstitution.
FDA Determined
Cause 2
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 and Original Applicant = DIAGNOSTIC SYSTEMS LABORATORIES, INC.