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U.S. Department of Health and Human Services

Class 2 Device Recall ARCHITECT c8000 Asay Disk, Version 5.00

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  Class 2 Device Recall ARCHITECT c8000 Asay Disk, Version 5.00 see related information
Date Initiated by Firm February 28, 2005
Date Posted October 06, 2005
Recall Status1 Terminated 3 on November 03, 2005
Recall Number Z-0008-06
Recall Event ID 33432
510(K)Number K980367  
Product Classification Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
Product ARCHITECT c800 for Conventional Units and for SI Units, Version 5.00.
Code Information List number 08G98-07 for Conventional Units; List number 04J62-07 for SI Units.
Recalling Firm/
Abbott Laboratories, Inc
1921 Hurd Drive
PO Box 152020
Irving TX 75038
Manufacturer Reason
for Recall
Device has incorrect notation associated with therapeutic drug monitoring assays.
FDA Determined
Cause 2
Action Firm sent device correction letters to consignees on 2/28/2005.
Quantity in Commerce 1,107 units worldwide
Distribution California, Louisiana, Massachusetts, North Carolina, Missouri, Oklahoma, Texas, Illinois, Minnesota, South Dakota, North Dakota and Arizona. Foreign countries: Mexico, Columbia, Chile, Canada, Germany, Singapore, China, Australia, and New Zealand
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