BEUDAMED
    FDA Recall Terminated

    ARCHITECT i System Assay CD-ROM, in vitro diagnostic analyzer, U.S. Version 21.0; for use on the ARCHITECT i System; Abbott Laboratories, Abbott Park, IL 60064; list number 06E58-21

    Recall: Z-0413-2007 · Initiated January 2, 2007

    Recall

    Recall Number
    Z-0413-2007
    Event Number
    37070
    Firm
    Abbott Laboratories MPG
    FEI Number
    1415939
    Product Code
    JJI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 2, 2007
    Posted
    March 8, 2007
    Terminated
    December 9, 2009
    Address
    100 Abbott Park Rd, Abbott Park, IL, 60064-3502

    Description

    ARCHITECT i System Assay CD-ROM, in vitro diagnostic analyzer, U.S. Version 21.0; for use on the ARCHITECT i System; Abbott Laboratories, Abbott Park, IL 60064; list number 06E58-21

    Reason

    The ARCHITECT AUSAB and ARCHITECT Anti-HCV assay parameter default interpretation screens when using ARCHITECT Assay CD-ROM US Version 06E58-21 does not align with the result interpretation options in the ARCHITECT AUSAB Reagent Package Insert (PI) 34-4162/R1 and ARCHITECT Anti-HCV PI 34-4152/R1.

    Action

    On 1/2/07, Abbott sent Product Correction, Immediate Action Required letters dated 12/29/06 to all ARCHITECT AUSAB (list number 1L82-25) and ARCHITECT Anti-HCV customers (list number 1L79-25) who have the affected assay CD-ROM. The end users were informed that for the ARCHITECT AUSAB and ARCHITECT Anti-HCV assays, the default interpretations in the Assay Parameters window, installed from ARCHITECT I System Assay CD-ROM US Version 06E58-21, are not align with the result interpretation options in the package inserts. The accounts were advised to reconfigure the names of the interpretations in Assay Parameters window, following the steps in the enclosed attachments A and B. The accounts were requested to keep a copy of the letter on file until the revised Assay CD-ROM is received. 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 AUSAB and/or Anti-HCV testing, and fax it to Abbott by 1/12/07.

    Distribution

    Nationwide

    Quantity

    51 affected analyzers