Class 2 Device Recall IMx CA 153 Reagent Pack

• Date Initiated by Firm: March 04, 2003
• Date Posted: March 26, 2003
• Recall Status: Terminated on September 15, 2004
• Recall Number: Z-0681-03
• Recall Event ID: 25690
• 510(K)Number: K964407
• Product Classification: System, Test, Immunological, Antigen, Tumor - Product Code MOI
• Product: IMx CA 15-3 Reagent Pack, list 6A75-22; this reagent pack contains one 4-mL bottle of Mode 1 Calibrator along with other reagents; Abbott Laboratories, Abbott Park, IL
• Code Information: list 6A75-22, lot 90843M200
• Recalling Firm/ Manufacturer: Abbott Laboratories HPD/ADD; 100/200 Abbott Park Road; Abbott Park IL 60064
• For Additional Information Contact: Abbott Customer Support; 877-422-2688
• Manufacturer Reason for Recall: The CA 15-3 Calibrators may cause depressed values for the CA 15-3 High Control and for patient specimens.
• FDA Determined Cause: Other
• Action: Recalled by letter dated 3/4/03. The accounts were informed of the depressed values for the CA 15-3 High Control and for patient specimens, and were requested to discontinue use and destroy any of the three affected lots found in inventory.
• Quantity in Commerce: 409 packs
• Distribution: Nationwide and Ecuador, England, Hong Kong, Chile, Japan, Canada, Singapore, Australia, Pakistan, Argentina, Thailand, Aruba, Korea and Jamaica.
• 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 = MOI