Class 2 Device Recall AEROSET

• Date Initiated by Firm: September 24, 2004
• Date Posted: October 09, 2004
• Recall Status: Terminated on November 03, 2005
• Recall Number: Z-0016-05
• Recall Event ID: 30114
• 510(K)Number: K980367
• Product Classification: Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
• Product: AEROSET Analyzer, Systems Operation Manual.
• Code Information: All Systems Operations Manuals
• Recalling Firm/ Manufacturer: Abbott Laboratories, Inc; 1921 Hurd Drive; PO Box 152020; Irving TX 75038
• Manufacturer Reason for Recall: Changes to the printer default settings made by users/operators cause printed data to be truncated and misidentified.
• FDA Determined Cause: Other
• Action: The recall was initiated by Device Correction Letter to all AEROSET customers. The Device Correction Letter will be provided to new customers until the new revision of the Operations Manual.
• Quantity in Commerce: 835 units
• Distribution: Nationwide and to: Mexico, Columbia, Puerto Rico, Germany, New Zealand, Guatemala, Argentina, Dominican Republic, Hong Kong, Romania, Venezuela, Brazil, Canada, and Australia
• 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