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U.S. Department of Health and Human Services

Class 2 Device Recall ARCHITECT c8000 Clinical Analyzer

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  Class 2 Device Recall ARCHITECT c8000 Clinical Analyzer see related information
Date Initiated by Firm May 23, 2008
Date Posted September 11, 2008
Recall Status1 Terminated 3 on April 26, 2010
Recall Number Z-2231-2008
Recall Event ID 48431
510(K)Number K980367  
Product Classification Clinical Chemistry Analyzer - Product Code CGZ
Product ARCHITECT c8000 Processing Module, for in vitro diagnostics; List Number 1G06-01 and 1G06-11, Affected software: v2.20, v2.20DB, v2.60, v3.10, 3.11 and 3.12; distributed by Abbott Laboratories, Irving, TX.

The Abbott ARCHITECT cSystem is designed to perform automated, random access, clinical chemistry analyzer which utilizes spectrophotometry (monochromatic and bichromatic modes of measurement) for photometric based determinations.
Code Information Version 2.20, List #05F48-13, Part #7-201738-01; Version 2.20DB, List #05F48-14, Part #7-201738-02; Version 2.60, List #05F48-17, Part #7-203715-01; Version 3.10, List #05F48-18, Part #7-203715-02; Version 3.11, List #05F48-20, Part 7-203715-03; and Version 3.12, List #05F48-21
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		 Software defect can allow tests ordered for one sample to be aspirated from a different sample, reporting erroneous results for the affected sample.
FDA Determined
Cause 2		 Software design
Action Firm notified all ARCHITECT c8000 customers with a correction letter and response form distributed on 5/23/2008. The letter provided actions the users could take until an updated software version was available. For assistance, contact Abbott at 1-877-4ABBOTT.
Quantity in Commerce 2,378 units worldwide (431 in the USA; plus 1,947 International)
Distribution Worldwide distribution, including: USA (including Puerto Rico), Argentina, Australia, Austria, Bahamas, Belgium, Bermuda, Bosnia and Herzegovina, Brazil, Cayman Islands, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, El Salvador, Finland, France, Germany, Grand Cayman, Greece, Guatemala, Honduras, Hong Kong, Hungary, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Korea, Lebanon, Luxembourg, Mexico, Netherlands, New Zealand, Norway, Oman, Panama, Peru, Poland, Portugal, Qatar, Russia, Saudi Arabia, Serbia and Montenegro, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, UAE, United Kingdom, 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 = CGZ and Original Applicant = ABBOTT LABORATORIES
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