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Medical Device Recalls
Class 3 Recall
ICT Calibrator
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Date Recall Initiated |
September 26, 2007
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Date Posted |
May 24, 2008
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Recall Number |
Z-1166-2008
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Product |
Clinical Chemistry ICT Calibrator, List Number: 1E46-02, Abbott Labs, Abbott Park, IL 60064
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Code Information |
Lot Number: 0505017
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Recalling Firm/ Manufacturer |
Abbott Laboratories, Inc
1921 Hurd Drive
PO Box 152020
Irving
, Texas
75038
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For Addition Information Contact |
Mark Littlefield
972-518-6062
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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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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.
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Quantity in Commerce |
1,377 Distributed Worldwide; 419 Domestically
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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.
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