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U.S. Department of Health and Human Services

Class 3 Device Recall ICT Calibrator

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  Class 3 Device Recall ICT Calibrator see related information
Date Initiated by Firm September 26, 2007
Date Posted May 24, 2008
Recall Status1 Terminated 3 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/
Abbott Laboratories, Inc
1921 Hurd Drive
PO Box 152020
Irving TX 75038
For Additional Information Contact Mark Littlefield
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 2
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 and Original Applicant = ABBOTT LABORATORIES