Class 3 Device Recall AxSYM System Tubing Decontamination Solution

• Date Initiated by Firm: February 18, 2009
• Date Posted: September 30, 2009
• Recall Status: Terminated on July 08, 2010
• Recall Number: Z-2317-2009
• Recall Event ID: 51258
• 510(K)Number: K974651
• Product Classification: Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
• Product: AxSYM System Tubing Decontamination Solution; 500 mL bottle; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064; List Number 07B05-09. To be used only for cleaning and inhibition of fouling bacteria in the tubing system of the in vitro immunoassay analyzer. This product does not disinfect or sterilize the tubing system.
• Code Information: List 7B05-09, Lot Number: 211974, expiration date 9/30/09.
• 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: Bottle labels from lot 211974, AxSYM System Tubing Decontamination Solution (List Number 7B05-09), were found to be missing the following information: lot number, date of manufacture, and expiration date.
• FDA Determined Cause: Manufacturing material removal
• Action: Abbott sent Product Recall Immediate Action Required letters dated February 18, 2009 to customers informing them of the affected product. Customers were instructed to examine their inventory and dispose all affected product. Accounts were requested to complete and fax back customer reply sheet acknowledging receipt of the letter, as well as the number of bottles destroyed, and to retain a copy of the letter for their records. For further information, contact Abbott Customer Service at 1-877-4ABBOTT.
• Quantity in Commerce: 1,965 kits
• Distribution: Worldwide Distribution -- United States including Puerto Rico and Argentina, Brazil, Canada, Chile, Columbia, Germany, Hong Kong, Japan, Mexico, Peru, South Korea, Thailand and Trinidad & Tobago.
• 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 = JJE