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U.S. Department of Health and Human Services

Class 2 Device Recall ARCHITECT c8000 System

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  Class 2 Device Recall ARCHITECT c8000 System see related information
Date Initiated by Firm September 14, 2005
Date Posted October 06, 2005
Recall Status1 Terminated 3 on September 25, 2007
Recall Number Z-0010-06
Recall Event ID 33460
510(K)Number K980367  
Product Classification Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
Product ARCHITECT c8000 Analyzer System Processing Module, a fully automated, random access, clinical chemistry analyzer which utilizes spectrophotometry (monochromatic and bichromatic modes of measurement) for photometric based determinations.
Code Information All serial numbers, List number 1G06-01
Recalling Firm/
Abbott Laboratories, Inc
1921 Hurd Drive
PO Box 152020
Irving TX 75038
Manufacturer Reason
for Recall
Software deficiency causing potential shift in absorbance readings for test results.
FDA Determined
Cause 2
Action Firm sent device correction letter to consignees on 9/14/2005.
Quantity in Commerce 1,107 units
Distribution Nationwide and 21 foreign countries. Foreign countries: Mexico, Guatemala, Venezuela, Colombia, Ecuador, Chile, Uruguay, Argentina, Brazil, Puerto Rico, Jamaica, San Salvador, Canada, Germany, Singapore, China, Thailand, Australia, New Zealand, Panama, and Grand Cayman
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