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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 30, 2003
Date Posted July 20, 2004
Recall Status1 Terminated 3 on April 07, 2004
Recall Number Z-0091-04
Recall Event ID 27495
510(K)Number K980367  
Product Classification Calculator/Data Processing Module, For Clinical Use - Product Code JQP
Product AEROSET System Software version 1.02ER000
Code Information Catalog 2-95068-01 AEROSET System Software 1.02ER000 and Catalog 2-95175-01 AEROSET System Software 1.02ER000 Upgrade Kit
Recalling Firm/
Manufacturer
Abbott Laboratories, Inc
1921 Hurd Drive
PO Box 152020
Irving TX 75015-2020
Manufacturer Reason
for Recall
Audible alarm occurs before aspiration potentially resulting in operator injury or results assigned to wrong patient for STAT samples.
FDA Determined
Cause 2
Other
Action The firm issued a letter on 09/30/2003 notifying customers of the Device Correction and provided instructions to disable the audible alert. Abbott Diagnostics will correct this issue in the next revision of the AEROSET System Software.
Quantity in Commerce 133
Distribution Nationwide and to the following foreign countries: Norway, United Kingdom, Hong Kong, United Arab Emirates, Canada, New Zealand, and China
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 = JQP and Original Applicant = ABBOTT LABORATORIES
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