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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 August 15, 2002
Date Posted May 20, 2003
Recall Status1 Terminated 3 on April 07, 2004
Recall Number Z-0844-03
Recall Event ID 25771
510(K)Number K980367  
Product Classification Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
Product AEROSET Analyzer
Code Information All AEROSET devices distributed prior to 08/15/2002.
Recalling Firm/
Abbott Laboratories, Inc
1921 Hurd Drive
PO Box 2020
Irving TX 75038
Manufacturer Reason
for Recall
Design of high concentration waste line causes formation of a precipitate in the waste line causing overflow of waste.
FDA Determined
Cause 2
Action The firm sent Technical Service Bulletins dated August 15, 2002 to consignees. Field Representatives are correcting the device in the field. A customer letter was released on August 20, 2002 to provide customers actions to take to prevent the occurrance.
Quantity in Commerce 578
Distribution Nationwide and to the following foreign countries: Mexico, Venezuela, Columbia, Argentina, Brazil, Puerto Rico, Dominican Republic, Canada, Germany, Hong Kong, New Zealand, and China
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