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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 March 19, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on November 03, 2005
Recall Number Z-0818-04
Recall Event ID 28728
510(K)Number K983212  K980367  
Product Classification Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
Product ARCHTECT System RS-232 Manual, product list number 06F71-04, for the ARCHITECT i2000 Processing Module and the ARCHITECT c8000 Processing Module. The product is manufactured and distributed by Abbott Laboratories Diagnostic Division, Irving, TX 75038
Code Information The RS-232 Manual is not controlled by control or lot numbers.
Recalling Firm/
Manufacturer		 Abbott Laboratories, Inc
1921 Hurd Drive
PO Box 152020
Irving TX 75015-2020
Manufacturer Reason
for Recall		 When using a LIS the software system will send up a test result of up to 20 characters although the field is set to display only 15 characters per the RS-232 Manual.
FDA Determined
Cause 2		 Other
Action Customers were notified by letter on March 23, 2004 to contact their LIS vendor and to reconfigure the ASTM Field 10.1.4 to allow a maximum character length of 20 characters.
Quantity in Commerce 101
Distribution Nationwide and to the following foreign countries: Chile, Canada, Germany, Taiwan, Australia, Signapore
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
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