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U.S. Department of Health and Human Services

Class 3 Device Recall

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  Class 3 Device Recall see related information
Date Initiated by Firm May 08, 2003
Date Posted May 29, 2003
Recall Status1 Terminated 3 on October 14, 2003
Recall Number Z-0872-03
Recall Event ID 26292
510(K)Number k973743  
Product Classification Radioimmunoassay, Estradiol - Product Code CHP
Product ACCESS Estradiol Reagent Test System
Code Information Lot number 215173
Recalling Firm/
Beckman Coulter Inc
200 South Kraemer Blvd W 337
Brea CA 92822
For Additional Information Contact Kathleen M Jaker
Manufacturer Reason
for Recall
Short volume, resulting possibility of falsely elevated results.
FDA Determined
Cause 2
Action Consignees were notified by letter dated may 8, 2003. It requests destruction of inventory for credit.
Quantity in Commerce 1593 kits
Distribution Nationwide and Canada
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 = CHP and Original Applicant = BECKMAN INSTRUMENTS, INC.