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Class 2 Device Recall Architect |
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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
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Product Classification |
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
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Product |
ARCHITECT Processing Module, List number 8C89-01, manufactured by Abbott Laboratories, Irving, Texas |
Code Information |
All units |
Recalling Firm/ Manufacturer |
Abbott Laboratories, Inc 1921 Hurd Drive PO Box 2020 Irving TX 75038
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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.
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FDA Determined Cause 2 |
Other |
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
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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.
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510(K) Database |
510(K)s with Product Code = JJE and Original Applicant = ABBOTT LABORATORIES
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