BEUDAMED
    FDA Recall Terminated

    TOSOH brand AIA-600 II Enzyme Immunoassay Analyzer; Software version 3.12, Catalog Numbers 019359, 019400; Model 019400, Smart Media

    Recall: Z-0218-05 · Initiated April 2, 2003

    Recall

    Recall Number
    Z-0218-05
    Event Number
    30183
    Firm
    Tosoh Bioscience, Inc.
    FEI Number
    1000123732
    Product Code
    NIG
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 2, 2003
    Posted
    November 30, 2004
    Terminated
    June 15, 2005
    Address
    347 Oyster Point Blvd, Ste 201, South San Francisco, CA, 94080-1913

    Description

    TOSOH brand AIA-600 II Enzyme Immunoassay Analyzer; Software version 3.12, Catalog Numbers 019359, 019400; Model 019400, Smart Media

    Reason

    A software upgrade was released by the firm for its AIA-600 II analyzers, in that washing deficiencies caused by the analyzer were corrected.

    Action

    The firm initiated the correction on 4/2/03 via telephone calls and PR on 11/24/04 to all its direct customers, however, the firm indicated that software upgrade was accomplished by the firm's Field Service Engineers.

    Distribution

    81 customers received the upgrade, including customers who received instruments with the upgrade installed already. 37 customers received the v.3.12 installation. In addition, TOSOH bioscience has identified 3 foreign and 5 US customers who required the upgrade. The firm had distributed to 3 US Government medical centers as well. These upgrades have been completed.

    Quantity

    81 units