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U.S. Department of Health and Human Services

Class 3 Device Recall ARCHITECT

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  Class 3 Device Recall ARCHITECT see related information
Date Initiated by Firm June 10, 2004
Date Posted August 13, 2004
Recall Status1 Terminated 3 on November 19, 2004
Recall Number Z-1341-04
Recall Event ID 29587
510(K)Number K980367  
Product Classification Electrode, Ion-Specific, Chloride - Product Code CGZ
Product ARCHITECT c8000 Processing Module; List Number 01G06-01. Manufactured by Toshiba Corporation, Medical Systems Division, Japan. Distributed by Abbott Laboratories Diagnostic Division, Irving, Texas
Code Information Serial numbers C800174 through C800346 and the following Serial numbers: C800072, C800122, C800131, and C800142
Recalling Firm/
Abbott Laboratories, Inc
1921 Hurd Drive
PO Box 152020
Irving TX 75038
Manufacturer Reason
for Recall
Process change in the manufacturing of the AC/DC driver board used on the analyzer may result in one or more of the solid state relays to fail during use.
FDA Determined
Cause 2
Action The firm initiated the recall by Technical Service Bulletin sent to affected customers. The AC/DC boards will be replaced on each analyzer by a firm representative.
Quantity in Commerce 171 units and 25 spare parts distributed
Distribution Product was distrbued nationwide and to the following foreign countries: Mexico, Australia, Germany, Hong Kong, Canada, Thailand, Grand Cayman, Chile, New Zealand, Columbia, Brazil, and Singapore.
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 = CGZ and Original Applicant = ABBOTT LABORATORIES