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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 12, 2002
Date Posted April 15, 2003
Recall Status1 Terminated 3 on October 28, 2004
Recall Number Z-0721-03
Recall Event ID 25236
Product Classification Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
Product AEROSET System Software version 1.00ER005 Catalog Number 2-89996-01 and 1.00ER005.2 Catalog Number 2-89996-02, distributed by Abbott Laboratories
Code Information Version 1.00ER005 Catalog Number 2-89996-01 and Version 1.00ER005.2 Catalog Number 2-89996-02  AEROSET System software is not controlled by Control or Lot numbers.
Recalling Firm/
Abbott Laboratories, Inc
1921 Hurd Drive
PO Box 2020
Irving TX 75038
Manufacturer Reason
for Recall
The autoprint feature allows the switch of patient IDs in remote cases.
FDA Determined
Cause 2
Action The firm sent a Device Correction letter to all consignees on 12/12/2002, requesting that the users make adjustments to their systems, and retain the letter in their user manual. The letter included a customer reply form. The software will be corrected with the release of the next version.
Quantity in Commerce 640
Distribution Nationwide and to the following foreign countries: Mexico, Columbia, Dominican Republic, Hong Kong, Guatemala, Argentina, Canada, Australia, Venezuela, Brazil, Germany, New Zeland
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.