Class 3 Device Recall AEROSET

• Date Initiated by Firm: December 29, 2000
• Date Posted: August 21, 2003
• Recall Status: Terminated on August 20, 2003
• Recall Number: Z-1142-03
• Recall Event ID: 26640
• 510(K)Number: K980367
• Product Classification: Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
• Product: Abbott Aeroset System list number 9D05-01, manufactured by Abbott Diagnostic Division, Irving, Texas
• Code Information: All units
• Recalling Firm/ Manufacturer: Abbott Laboratories, Inc; 1921 Hurd Drive; PO Box 2020; Irving TX 75038
• Manufacturer Reason for Recall: ICT assays run using a manual dilution will not be calculated correctly by the software.
• FDA Determined Cause: Other
• Action: Product Information letter dated 29 December 2000 was sent to all AEROSET customers.
• Quantity in Commerce: 143
• Distribution: Nationwide and to the following countries: Brazil, Canada, Australia, New Zealand, Columbia, Venezuela, Argentina, Finland, France, Germany, Greece, Hong Kong, United Kingdom, Japan, Singapore, China, Italy, Ireland, Korea, Thailand, Turkey, Norway, India
• 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