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Class 3 Device Recall AEROSET |
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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
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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/ Manufacturer |
Abbott Laboratories, Inc 1921 Hurd Drive PO Box 2020 Irving TX 75038
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Manufacturer Reason for Recall |
The autoprint feature allows the switch of patient IDs in remote cases.
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FDA Determined Cause 2 |
Other |
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
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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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