Class 3 Device Recall ICT Calibrator

• Date Initiated by Firm: September 26, 2007
• Date Posted: May 24, 2008
• Recall Status: Terminated on March 27, 2012
• Recall Number: Z-1166-2008
• Recall Event ID: 46389
• 510(K)Number: K980367
• Product Classification: Ion-specific chloride electrode - Product Code CGZ
• Product: Clinical Chemistry ICT Calibrator, List Number: 1E46-02, Abbott Labs, Abbott Park, IL 60064
• Code Information: Lot Number: 0505017
• Recalling Firm/ Manufacturer: Abbott Laboratories, Inc; 1921 Hurd Drive; PO Box 152020; Irving TX 75038
• For Additional Information Contact: Mark Littlefield; 972-518-6062
• Manufacturer Reason for Recall: Quality Control (Out of Range)- ICT Calibrator lot number: 0505017, may contain an interferent. Not all vials within a kit are affected. The investigation determined that the interferent affects Potassium (K+) only. Use of the affected calibrator vials will generate an acceptable, but low calibration slope. When Quality Control (QC) is run to verify the calibration, K+ QC results may be bel
• FDA Determined Cause: Component design/selection
• Action: An Immediate Action Product Recall dated 9/26/07, was provided to all AEROSET and ARCHITECT cSYSTEM customers that have received Lot Number 0505017. The effectiveness check will be completed through a customer reply form for 100% of US customers. Outside of the U.S. each individual country will determine the methods of effectiveness check. Necessary Actions: If the ICT calibration generates an acceptable slope for (K+), and the calibration is verified by generating QC results within the acceptable range, then the customers may continue to use the lot until a new one is available. If the ICT calibration generates an acceptable slope for (K+) with results below QC range, and (Na+) and (Cl-) are not affected, then they should discontinue use of the Calibrator vials that generate the unacceptable calibration and destroy them following their laboratory procedures. If (Na+) and/or (Cl-) calibration slopes or QC results are not acceptable, additional troubleshooting is required. Questions may be addressed to Abbott Customer Support at 1-877-4ABBOTT.
• Quantity in Commerce: 1,377 Distributed Worldwide; 419 Domestically
• Distribution: Worldwide Distribution --- including USA, Puerto Rico and countries of Mexico, Ecuador, Brazil, Canada, Hong Kong, New Zealand, Venezuela, Chile, , Germany, Thailand, Trinidad/Tobago, Columbia, Argentina, El Salvador, Singapore, Australia, and the Bahama.
• 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 = CGZ