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Class 3 Device Recall ICT Calibrator |
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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
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Product Classification |
Ion-specific chloride electrode - Product Code CGZ
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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
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For Additional Information Contact |
Mark Littlefield 972-518-6062
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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
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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
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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.
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510(K) Database |
510(K)s with Product Code = CGZ and Original Applicant = ABBOTT LABORATORIES
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