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U.S. Department of Health and Human Services

Class 3 Device Recall ARCHITECT c8000 System

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  Class 3 Device Recall ARCHITECT c8000 System see related information
Date Initiated by Firm December 08, 2005
Date Posted January 18, 2006
Recall Status1 Terminated 3 on September 25, 2007
Recall Number Z-0398-06
Recall Event ID 34266
510(K)Number K980367  
Product Classification Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
Product ARCHITECT c8000 System Software, Version 2.11, Product List/Model #5F48-12, distributed by Abbot Laboratories, Irving, TX.
Code Information All lots/serial numbers.
Recalling Firm/
Manufacturer
Abbott Laboratories, Inc
1921 Hurd Drive
PO Box 152020
Irving TX 75038
Manufacturer Reason
for Recall
System software assigns a calibrator default volume of 2.0uL when field is left empty by operator at time assay parameters set. Patient results could be affected if the volume required is not 2.0 uL.
FDA Determined
Cause 2
Other
Action Firm initiated recall to all consignees via letter dated 12/08/05.
Quantity in Commerce 1206 units.
Distribution Worldwide. Product distributed nationwide to direct accounts (including gov''t accounts) in: AL, AZ, CA, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MO, MN, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI and WY. Foreign distribution to the following countries: Argentina, Australia, Bermuda, Brazil, Canada, Chile, Columbia, Ecuador, El Salvador, Germany, Grand Cayman, Guatemala, Hong Kong, Jamaica, Mexico, New Zealand, Panama, Puerto Rico, Singapore, Thailand, Trinidad, Uruquay 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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