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Class 2 Device Recall ARCHITECT c8000 System |
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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
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Product Classification |
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
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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/ Manufacturer |
Abbott Laboratories, Inc 1921 Hurd Drive PO Box 152020 Irving TX 75038
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Manufacturer Reason for Recall |
Software deficiency causing potential shift in absorbance readings for test results.
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FDA Determined Cause 2 |
Other |
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
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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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