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U.S. Department of Health and Human Services

Class 2 Device Recall Architect

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  Class 2 Device Recall Architect see related information
Date Initiated by Firm December 10, 2001
Date Posted August 13, 2003
Recall Status1 Terminated 3 on August 12, 2003
Recall Number Z-1133-03
Recall Event ID 26639
510(K)Number K983212  
Product Classification Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
Product ARCHITECT Processing Module, List number 8C89-01, manufactured by Abbott Laboratories, Irving, Texas
Code Information All units
Recalling Firm/
Abbott Laboratories, Inc
1921 Hurd Drive
PO Box 2020
Irving TX 75038
Manufacturer Reason
for Recall
Under specific conditions, the system can allow an incorrect sample ID to be assigned to another sample in a different carrier.
FDA Determined
Cause 2
Action Technical Service Bulletin 114-041 was sent to the Abbott Laboratories Field Service Organization with instructions to correct all ARCHITECT i 2000 systems worldwide.
Quantity in Commerce 787
Distribution Nationwide and to the following foreign countries: Canada, Mexico, Venezuela, Chile, Brazil, Germany, Japan, Singapore, Hong Kong, Taiwan, Thailand, Korea, Australia, New Zealand.
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