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U.S. Department of Health and Human Services

Class 2 Device Recall

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  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/
Manufacturer		 Beckman Coulter Inc
200 South Kraemer Blvd W 337
Brea CA 92822
For Additional Information Contact Kathleen Jaker
714-961-3626
Manufacturer Reason
for Recall		 Failure to meet sensitivity claims at end of shelf life. Potential for false negative reports.
FDA Determined
Cause 2		 Other
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.
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