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U.S. Department of Health and Human Services

Class 2 Device Recall ARCHITECT i1000SR System Assay CD ROM WW (excluding US)

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 Class 2 Recall
ARCHITECT i1000SR System Assay CD ROM WW (excluding US)
see related information
Date Posted September 19, 2008
Recall Status1 Terminated on March 18, 2010
Recall Number Z-2239-2008
Recall Event ID 48701
Product Classification Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
Product ARCHITECT i1000SR System Assay CD ROM WW (excluding US) Special edition Version 1.01 and Version 2.0; list 01P61-01 and 01P61-02. The device is intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity.
Code Information List 01P61, Special edition Version 1.01 and Version 2.0, Assay CD-ROM lot number 63062P100
Recalling Firm/
Manufacturer
Abbott Laboratories
100 Abbott Park Rd
Abbott Park, Illinois 60064-3502
For Additional Information Contact Abbott Customer Support
877-422-2688
Manufacturer Reason
for Recall
When running the Automated Dilution Protocol with the assay files "CMV IgG" or "Toxo IgG" on the ARCHITECT i1000SR system, a software error [9010 (Pipettor Robotics) preventing (Process Path) from operating] is generated and the instrument stops running. No results are generated.
FDA Determined
Cause 2
DESIGN: Software Design
Action Abbott affiliates were e-mailed copies of the recall letter Urgent Field Safety Notice Product Correction on 6/16/08 for translation where needed and dissemination to their ARCHITECT accounts who have the affected assay CD-ROMs. Each Abbott international organization will be responsible for contacting customers and determining the method of effectiveness checks based on their country requirements. Abbott sent Product Correction, Immediate Action Required letters dated June 16, 2008 to all active non-U.S. ARCHITECT customers who have the affected assay CD-ROMs. The end users were informed when running the Automated Dilution Protocol of the ARCHITECT CMV IgG and Toxo IgG assays on the ARCHITECT i1000SR System, software error code [9010 (Pipettor Robotics) preventing (Process Path) from operating] is generated and the instrument stops. The accounts were advised to not use the Automated Dilution Protocol of either the ARCHITECT CMV IgG and Toxo IgG assays on the ARCHITECT i1000SR System and report results for samples requiring dilution as ">250.0 AU/mL" for CMV IgG and ">200.0 IU/mL" for Toxo IgG until a corrected version of the ARCHITECT i1000SR System Assay CD-ROM is available in late September 2008. The accounts were requested to keep a copy of the letter on file. The accounts were requested to complete the customer reply form, indicating that the letter was received, understood and disseminated to the laboratory manager/supervisor responsible for Architect testing, and fax it to Abbott by 7/1/08 at 1-800-777-0051. If you have question, contact your local area Customer Support.
Quantity in Commerce 75 CD-ROMs
Distribution Austria, Belgium, Czech Republic, Denmark, France, Germany, Iceland, India, Italy, Latvia, Lithuania, Netherlands, Poland, Portugal, Sweden, Saudi Arabia, Spain, United Arab Emirates
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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