Class 2 Device Recall ARCHITECT LH Reagent

• Date Initiated by Firm: November 22, 2006
• Date Posted: January 11, 2007
• Recall Status: Terminated on December 09, 2009
• Recall Number: Z-0488-2007
• Recall Event ID: 36889
• Product Classification: in vitro diagnostic - Product Code CEP
• Product: ARCHITECT LH Reagent, each kit contains bottles of Anti-Beta LH coated Microparticles and bottles of Anti-Alpha LH acridinium-labeled Conjugate; list numbers 6C25-22 (4 x 100 tests), 6C25-27(1 x 100 tests), and 6C25-30 (4 x 500 tests); Abbott Laboratories, Abbott Park, IL 60064-3500
• Code Information: lot numbers 33198M200 and 41861M100, 33198M201, and 33871M100. All lots expire 6/16/2007.
• FEI Number: 1415939
• Recalling Firm/ Manufacturer: Abbott Laboratories MPG; 100 Abbott Park Rd; Abbott Park IL 60064-3502
• For Additional Information Contact: Abbott Customer Support ; 877-422-2688
• Manufacturer Reason for Recall: The lots of ARCHITECT LH Reagent List 6C25-22, have the potential to generate patient specimen results that are elevated. Correlation studies have demonstrated an upward shift in slope for patient results of approximately 13% on average when compared to other currently available reagent lots and an average bias from patient specimens of 13% to 17% has been observed.
• FDA Determined Cause: Other
• Action: Abbott initiated a field correction recall by letter dated 11/22/06 to all customers receiving the affected reagent. The accounts were informed of the elevated patient results with the affected lots of reagents. The accounts were requested to assess the inventory for the affected lots of reagents, discontinue use of the lots and destroy the remaining inventory of the lots, recording the number of kits on the customer reply form and faxing it to Abbott by 12/6/06, indicating that the letter was received and understood. Credit 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: 2,960 kits
• Distribution: Worldwide distribution including U.S.A., Puerto Rico, Canada, Mexico, Venezuela, Colombia, Chile, Uruguay, Argentina, Brazil, Dominican Republic, 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.