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U.S. Department of Health and Human Services

Class 2 Device Recall AEROSET

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  Class 2 Device Recall AEROSET see related information
Date Initiated by Firm September 24, 2004
Date Posted October 09, 2004
Recall Status1 Terminated 3 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 2
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 and Original Applicant = ABBOTT LABORATORIES
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