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U.S. Department of Health and Human Services

Class 2 Device Recall ARCHITECT cSystem

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  Class 2 Device Recall ARCHITECT cSystem see related information
Date Initiated by Firm September 05, 2007
Date Posted November 07, 2007
Recall Status1 Terminated 3 on October 04, 2010
Recall Number Z-0146-2008
Recall Event ID 44961
510(K)Number K980367  
Product Classification Processing Module, for In Vitro Diagnostics; - Product Code JJE
Product ARCHITECT c8000 Processing Module, for In Vitro Diagnostics; List Number 106-01; Affected software: v2.10, v2.11, v2.12, v2.20, v2.20DB, v2.30, v2.60, v3.00 and v3.10; Distributed by Abbott Laboratories, Irving, TX.
Code Information All Serial Numbers: ARCHITECT cSystems using ARCHITECT System Software Versions: ---Software Version--List Number--Part Number-- 2.10-- 05F48-11-- 7-99077-01 2.11-- 05F48-12 --7-99077-02 2.12 --None --------7-99077-03 2.20 --05F48-13 ---7-201738-01 2.20DB --05F48-14 ---7-201738-02 2.30-- None --202246-01 2.60-- 05F48-17-- 7-203715-01 3.00-- 05F48-15-- 7-202246-01 3.10-- 05F48-18-- 7-203715-02 
Recalling Firm/
Manufacturer
Abbott Laboratories, Inc
1921 Hurd Drive
PO Box 152020
Irving TX 75038
For Additional Information Contact
972-518-6154
Manufacturer Reason
for Recall
Incorrect Sample/Test Identification: Due to a software timing defect with certain versions of ARCHITECT cSystem Software, test results may be incorrectly associated to a Sample Identification during specific sample-processing conditions of the Robotic Sample Handler.
FDA Determined
Cause 2
Software change control
Action Notification letters sent to consignees on 09/17/07. Consignees informed of the software defect and the conditions that would cause the software error to occur. Consignees told they would be contacted by an Abbott Field Service Rep who would install ARCHITECT System Software v3.11 and were asked to respond via fax using Customer Reply form acknowledging receipt and understanding of correction letter. Firm recalling to hospital/user level.
Quantity in Commerce 2070 units.
Distribution Worldwide Distribution: USA (including Puerto Rico), Argentina, Australia, Bahamas, Bermuda, Brazil, Cayman Islands, Canada, Chile, China, Colombia, Dominican Republic, Ecuador, El Salvador, Germany, Guatemala, Hong Kong, Jamaica, Mexico, New Zealand, Panama, Singapore, Thailand, Trinidad and Tobago, Uruguay, and Venezuela.
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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