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U.S. Department of Health and Human Services

Class 2 Device Recall AEROSET

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  Class 2 Device Recall AEROSET see related information
Date Initiated by Firm February 24, 2003
Date Posted May 01, 2003
Recall Status1 Terminated 3 on October 28, 2004
Recall Number Z-0788-03
Recall Event ID 25621
510(K)Number K980367  
Product Classification Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
Product AEROSET ICT Module, Reagent module for sodium, potassium, and chloride. List number 9D05-01.
Code Information All lots
Recalling Firm/
Manufacturer		 Abbott Laboratories, Inc
1921 Hurd Drive
PO Box 2020
Irving TX 75038
Manufacturer Reason
for Recall		 Software failure to detect error in reference solution set-up can cause inaccurate results for Sodium, Potassium, and Chloride.
FDA Determined
Cause 2		 Other
Action A Device Correction Letter was sent to all AEROSET System customers on 2/24/2003 informing them of the issue and measure they must take to minimize the risk of occurrence.
Quantity in Commerce 645 units
Distribution Nationwide and to the following countries: Mexico, Guatemala, Venezuela, Columbia, Argentina, Brazil, Puerto Rico, Dominican Republic, Canada, Germany, Hong Kong, Australia, New Zealand
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 and Original Applicant = ABBOTT LABORATORIES
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