• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back to Search Results
  Class 2 Device Recall see related information
Date Initiated by Firm February 20, 2003
Date Posted April 02, 2003
Recall Status1 Terminated 3 on September 25, 2003
Recall Number Z-0706-03
Recall Event ID 25741
510(K)Number K993203  
Product Classification Visual, Pregnancy Hcg, Prescription Use - Product Code JHI
Product ICON DS hCG, an in-vitro diagnostic. Part number 44025.
Code Information Lot numbers hCG010401, hCG010704, hCG010902
Recalling Firm/
Beckman Coulter Inc
200 South Kraemer Blvd W 337
Brea CA 92822
For Additional Information Contact Kathleen Jaker
Manufacturer Reason
for Recall
Failure to meet sensitivity claims at end of shelf life. Potential for false negative reports.
FDA Determined
Cause 2
Action Distributors/customers were sent a recall letter dated 2/20/03 instructing them to discontinue use of the product.
Quantity in Commerce 12,804
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 = JHI and Original Applicant = ACON LABORATORIES, INC.