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U.S. Department of Health and Human Services

Class 3 Device Recall DiaSorin Gamma Coat Androstenedione 125I RIA Kit

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  Class 3 Device Recall DiaSorin Gamma Coat Androstenedione 125I RIA Kit see related information
Date Initiated by Firm May 25, 2004
Date Posted April 13, 2005
Recall Status1 Terminated 3 on July 22, 2006
Recall Number Z-0704-05
Recall Event ID 30932
510(K)Number K854650  
Product Classification Radioimmunoassay, Androstenedione - Product Code CIZ
Product DiaSorin GammaCoat Androstenedione - 125 I, RIA Kit for the quantitative determination of androstenedione levels in serum. Catalog No. CA-1725. Lot # 04164. DiaSorin Stillwater, Minnesota 55082-0285, U.S.A.
Code Information catalog # CA 1725, lot # 04164
Recalling Firm/
Manufacturer		 Diasorin Inc.
1951 Northwestern Ave S
Stillwater MN 55082-7536
For Additional Information Contact DiaSorin Technical Services
800-328-1482
Manufacturer Reason
for Recall		 Standards contained in the GammaCoat Androstenedione RIA Kit appeared yellowish in color and were gelatinous upon reconstitution. The assay validation criteria failed when the gelatinous standards were used.
FDA Determined
Cause 2		 Other
Action Customers were sent notification letters informing them of the product and problem and recommended the destruction of any remaining inventory. Letter also requested the completion and return of the lower portion of the letter.
Quantity in Commerce 70 kits
Distribution Massachusetts, Saudi Arabia, Sweden, Germany, Spain, Belgium, Italy, Camada. Australia, Portugal, Hungary, 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.
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