BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-2231-2008 · Initiated May 23, 2008

    Recall

    Recall Number
    Z-2231-2008
    Event Number
    48431
    Firm
    Abbott Laboratories, Inc
    FEI Number
    1628664
    Product Code
    CGZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    May 23, 2008
    Posted
    September 11, 2008
    Terminated
    April 26, 2010
    Address
    1921 Hurd Drive PO Box 152020, Irving, TX, 75038

    Description

    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.

    Reason

    Software defect can allow tests ordered for one sample to be aspirated from a different sample, reporting erroneous results for the affected sample.

    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.

    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.

    Quantity

    2,378 units worldwide (431 in the USA; plus 1,947 International)