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Class 2 Device Recall ARCHITECT i2000 |
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Date Initiated by Firm |
November 17, 2003 |
Date Posted |
December 24, 2003 |
Recall Status1 |
Terminated 3 on October 28, 2004 |
Recall Number |
Z-0262-04 |
Recall Event ID |
27731 |
510(K)Number |
K983212
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Product Classification |
Calculator/Data Processing Module, For Clinical Use - Product Code JQP
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Product |
The ARCHITECT i2000, Clinical Chemistry Analyzer, Manufactured by Abbott Laboratories, Irving, Texas |
Code Information |
List number 3M74-01, all serial numbers |
Recalling Firm/ Manufacturer |
Abbott Laboratories, Inc 1921 Hurd Drive PO Box 152020 Irving TX 75015-2020
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Manufacturer Reason for Recall |
Sample Identification (SID) numbers of a bar coded sample may be truncated, or shortened, after being scanned by the bar code reader (e.g. an actual SID of 123456 is shortened to 1234)
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FDA Determined Cause 2 |
Other |
Action |
The firm plans to distribute a Product Information Letter and an updated ARCHITECT i System Operations Manufal Addendum to all US ARCHITECT customers. An electronic version of these documents was sent to all Abbott affilities worldwide for distribution to their ARCHITECT customers. |
Quantity in Commerce |
223 |
Distribution |
Mexico, Puerto Rico, Japan, Taiwan, Australia, Colombia, Cananda, Hong Kong, New Zealand, Netherlands, Singapore, Germany, Grand Cayman, Korea, Chile, Thailand, TX, PA, SC, CA, IN. |
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 = JQP and Original Applicant = ABBOTT LABORATORIES
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