Class 3 Device Recall CA 153 Controls

• Date Initiated by Firm: June 09, 2006
• Date Posted: July 18, 2006
• Recall Status: Terminated on January 18, 2008
• Recall Number: Z-1244-06
• Recall Event ID: 35627
• 510(K)Number: K964407 K963926
• Product Classification: System, Test, Immunological, Antigen, Tumor - Product Code MOI
• Product: CA 15-3 Controls, list 9C08-10; an In Vitro diagnostic for use with the AxSYM or IMx CA 15-3 reagents, calibrators and instruments; each kit contains 2 bottles with 115D8:DF3 reactive determinants (human) prepared in TRIS buffer with protein (bovine) stabilizers to yield the following assay values (U/ml): Control L - 35 and Control H - 150; Abbott Laboratories, Abbott Park, IL 60064
• Code Information: list 9C08-10; lot number 29506M100, expiration date July 5, 2006
• 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 CA 15-3 Controls replicates out of range high resulting in invalid runs.
• FDA Determined Cause: Other
• Action: Abbott initiated a field correction recall by letter dated 6/9/06 and sent on 6/12/06 to all customers receiving the affected controls. The accounts were informed of the increase in invalid runs due to controls outside of the package insert range with this lot of CA 15-3 Controls. The accounts were requested to assess the inventory for the affected lot of controls, discontinue use of the lot and destroy the remaining inventory of the lot, recording the number of kits on the customer reply form and faxing it to Abbott by 6/21/06, 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: 1794 kits
• Distribution: Worldwide, including U.S.A., Puerto Rico, Canada, Mexico, Ecuador, Chile, Argentina, Brazil, Germany, Japan, SIngapore, Hong Kong, Thailand, South Korea and Australia.
• 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 and Original Applicant = ABBOTT LABORATORIES