BEUDAMED
    FDA Recall Terminated

    REF 822 IMUBIND(R) Plasma PAI-1 ELISA The intended use: Product is an enzyme-linked immunosorbent assay for the quantative measurement of human Plasminogen Activator Inhibitor Type-1 (PA-1) antigen in plasma.

    Recall: Z-1426-2010 · Initiated March 5, 2010

    Recall

    Recall Number
    Z-1426-2010
    Event Number
    54858
    Firm
    American Diagnostica, Inc.
    FEI Number
    1220602
    Product Code
    GGP
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    March 5, 2010
    Posted
    April 21, 2010
    Terminated
    July 29, 2016
    Address
    500 West Ave, Stamford, CT, 06902

    Description

    REF 822 IMUBIND(R) Plasma PAI-1 ELISA The intended use: Product is an enzyme-linked immunosorbent assay for the quantative measurement of human Plasminogen Activator Inhibitor Type-1 (PA-1) antigen in plasma.

    Reason

    Unacceptable microwell to microwell variation in the section of the plate that is typically used for the calibrators

    Action

    Three emails "REF 822 lot 102401 needs to be recalled" dated March 1, 2010 was sent to three customers. The emails described the product, problem and action to be taken by the customers. The customers should send the kit to the firm (SEKISUI american diagnostica inc.) attention of Leigh Ayres, Director, Regulatoy Affairs and Quality Assurance. If you have any question, please call 1-203-602-7777.

    Distribution

    Worldwide distribution: USA and UK, Taiwan and Korea.

    Quantity

    25 kits