Class 2 Device Recall

• Date Initiated by Firm: February 20, 2003
• Date Posted: April 02, 2003
• Recall Status: Terminated 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: 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