Class 3 Device Recall ARCHITECT Estradiol Reagent

• Date Initiated by Firm: February 19, 2007
• Date Posted: April 07, 2007
• Recall Status: Terminated on January 09, 2008
• Recall Number: Z-0728-2007
• Recall Event ID: 37446
• Product Classification: Estradiol Reagent - Product Code CHP
• Product: ARCHITECT Estradiol Reagent, each kit contains bottles of coated Microparticles and bottles of Conjugate; 400 Test Kit-list number 2K25-20 (4 x 100 tests) and 100 Test Kit-list number 2K25-25 (1 x 100 tests); Abbott Laboratories, Abbott Park, IL 60064-3500
• Code Information: 400 Test Kit Lot Number: 42462M100 and 100 Test Kit Lot Number: 42462M101
• Recalling Firm/ Manufacturer: Abbott Laboratories; 100 Abbott Park Rd; Abbott Park IL 60064-3502
• For Additional Information Contact: Abbott Customer Support ; 877-422-2688
• Manufacturer Reason for Recall: A small number of reagent kits were incorrectly configured. The affected kits contain either two bottles of conjugate or two bottles of assay diluent instead of one bottle of each.
• FDA Determined Cause: Other
• Action: Abbott initiated a field correction recall by letter dated 2/19/07 to all customers receiving the affected reagent. The accounts were informed of the incorrectly configured reagent kits. The accounts were requested to assess the inventory for the affected lots of reagents, inspect each kit and destroy any kits incorrectly configured, recording the number of kits inspected and the number of kits discarded on the customer reply form and faxing it to Abbott by 3/2/07, indicating that the letter was received and understood. Replacement kits will be issued for the number of kits destroyed, as indicated on the reply sheet. Customers requiring additional information were directed to contact Abbott Customer Service at 1-877-422-2688.
• Quantity in Commerce: 1,944 kits
• Distribution: Worldwide distribution including U.S.A., Puerto Rico, Canada, Mexico, Venezuela, Chile, Uruguay, Argentina, Brazil, Germany, Japan, Singapore, Hong Kong, Taiwan, Thailand, South Korea, Australia, New Zealand and Panama.
• 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.