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Class 3 Device Recall AEROSET |
![see related information](../images/related-info.gif) |
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
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Product Classification |
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
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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
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Manufacturer Reason for Recall |
ICT assays run using a manual dilution will not be calculated correctly by the software.
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FDA Determined Cause 2 |
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
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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.
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510(K) Database |
510(K)s with Product Code = JJE and Original Applicant = ABBOTT LABORATORIES
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