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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 October 02, 2001
Date Posted May 20, 2003
Recall Status1 Terminated 3 on April 07, 2004
Recall Number Z-0843-03
Recall Event ID 25770
510(K)Number K980367  
Product Classification Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
Product Aeroset Analyzer, item 9D05-01
Code Information All units on the market prior to 12/3/2001.
Recalling Firm/
Abbott Laboratories, Inc
1921 Hurd Drive
PO Box 2020
Irving TX 75038
Manufacturer Reason
for Recall
Extensive use of cuvettes causes inaccurate results. Preventative maintenance did not specify replacement schedule.
FDA Determined
Cause 2
Action The firm issued a letter to affected consignees on or about 10/02/2001 notifying the consignees that an Abbott Field Representative will perform a one-time cuvette upgrade to the consignee''s AEROSET system.
Quantity in Commerce 238 units
Distribution Nationwide and to the following foreign countries: Mexico, Guatemala, Venezuela, Columbia, Argentina, Brazil, Dominican Republic, Canada, Germany, Hong Kong, Australia, New Zealand, China, England
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