BEUDAMED
    FDA Enforcement Class III Terminated

    Presage ST2 Assay, catalog numbers BC-1065 and BC-1065E. The Critical Diagnostics Presage ST2 Assay kit is an in vitro diagnostic device that quantitatively measures ST2 in serum or plasma by enzyme-linked immunosorbent assay (ELISA) in a microtiter plate format. The Presage ST2 Assay is indicated to be used in conjunction with clinical evaluation as an aid in assessing the prognosis of patients diagnosed with chronic heart failure.

    Recall: Z-2012-2012 · Reported July 25, 2012

    Enforcement

    Recall Number
    Z-2012-2012
    Event ID
    62281
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Critical Diagnostics
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 25, 2012
    Initiation Date
    February 28, 2012
    Classification Date
    July 13, 2012
    Termination Date
    July 16, 2012
    Address
    3030 Bunker Hill St Ste 115a, San Diego, CA, 92109-5754, United States

    Description

    Presage ST2 Assay, catalog numbers BC-1065 and BC-1065E. The Critical Diagnostics Presage ST2 Assay kit is an in vitro diagnostic device that quantitatively measures ST2 in serum or plasma by enzyme-linked immunosorbent assay (ELISA) in a microtiter plate format. The Presage ST2 Assay is indicated to be used in conjunction with clinical evaluation as an aid in assessing the prognosis of patients diagnosed with chronic heart failure.

    Reason

    The recall was initiated because Critical Diagnostics has confirmed that it is possible to obtain inaccurate test results for specimens when using the Presage ST2 Assay kits.

    Code Info

    BC-1065 (US distribution) Lot No. RN-43116-4 BC-1065 E (European Distribution) Lot No. RN-42467-1, RN-42467-2, RN-43116-1, RN-43116-2, RN-43116-3.

    Distribution

    USA including the state of California and the countries of Austria, Spain, United Kingdom, and Italy.

    Quantity

    33 units