BEUDAMED
    FDA Enforcement Class III Terminated

    PHADIA Varelisa Cardiolipin IgM Cardiolipin autoantibody immunological test system (IgM class antibodies)

    Recall: Z-2285-2012 · Reported September 5, 2012

    Enforcement

    Recall Number
    Z-2285-2012
    Event ID
    62572
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Phadia US Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 5, 2012
    Initiation Date
    August 2, 2012
    Classification Date
    August 28, 2012
    Termination Date
    December 12, 2012
    Address
    4169 Commercial Ave, N/A, Portage, MI, 49002-9701, United States

    Description

    PHADIA Varelisa Cardiolipin IgM Cardiolipin autoantibody immunological test system (IgM class antibodies)

    Reason

    Customers were not following the labeled assay procedure. This was due to a letter issued to them in 2004 from Phadia GmbH, which indicated that customers could omit the pre-wash step. The omission of the pre-wash step, when combined with a change in material source in kit lot #0067, caused elevated results.

    Code Info

    Article Number 15696 Lot number #0067

    Distribution

    USA Nationwide.

    Quantity

    837 kits (96 assays per kit), total of 80,352 individual assays