Class 2 Device Recall AxSYM HBsAg Reagent Pack

• Date Initiated by Firm: April 23, 2007
• Date Posted: July 11, 2007
• Recall Status: Terminated on May 18, 2008
• Recall Number: Z-1040-2007
• Recall Event ID: 37887
• PMA Number: P050049
• Product Classification: Reagent - Product Code LOM
• Product: AxSYM HBsAg Reagent Pack; list 09B01; 100 test pack; in-vitro diagnostic; Abbott Laboratories, Abbott Park, IL 60064
• Code Information: list 09B01; lots 49492M200, 50261M100, 50672M100
• 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: Failure of the AxSYM instrument to open (actuate) some reagent packs from certain lots. The defects can result in probe crashes if not detected prior to placement of the reagent kit on the AxYM instrument.
• FDA Determined Cause: Other
• Action: Abbott initiated a field correction recall by letter dated 4/23/07 to all customers receiving the affected reagents. The accounts were informed of the failure of the AxSYM to open (actuate) some reagent packs with the affected lots. The accounts were requested to inspect each reagent pack for broken or improperly sealed caps; manually open each bottle to ensure the flipper bar raises the reagent cap correctly; close each flipper bar prior to loading the reagent pack on the instrument; and discard any reagent packs that do not open properly. If the user observes a probe crash, prior to testing samples again, the user must perform a probe crash recovery following the procedure in the Operations Manual. If necessary, they need to replace the probe. If a probe crash recovery is not performed, subsequent results may be impacted. The customers were requested to retain a copy of the letter for their records. Customers requiring additional information were directed to contact Abbott Customer Service at 1-877-422-2688.
• Quantity in Commerce: 1,121 packs
• Distribution: Worldwide, including USA, Puerto Rico, Argentina, Australia, Brazil, Canada, Cayman Islands, Chile, Colombia, Ecuador, Germany, Hong Kong, Mexico, New Zealand, Singapore, South Korea, Taiwan, Thailand and Venezuela.
• 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.

• PMA Database: PMAs with Product Code = LOM