Company: Abbott Laboratories
Date of Enforcement Report 10/15/2008
Class:ll
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, Recall # Z-2239-2008
REASON
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.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Abbott Park, IL, by letter on June 16, 2008. Firm initiated recall is ongoing.
VOLUME OF PRODUCT 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