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U.S. Department of Health and Human Services

Class 3 Device Recall AEROSET

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  Class 3 Device Recall AEROSET see related information
Date Initiated by Firm December 29, 2000
Date Posted August 21, 2003
Recall Status1 Terminated 3 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/
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 2
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 and Original Applicant = ABBOTT LABORATORIES