Class 2 Device Recall AEROSET

• Date Initiated by Firm: August 15, 2002
• Date Posted: May 20, 2003
• Recall Status: Terminated 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/ Manufacturer: 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: Other
• 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