BEUDAMED
    FDA Enforcement Class III Terminated

    Quidel MicroVue Intact PTH EIA, Model 8044. An enzyme immunoassay for the quantification of Intact Parathyroid Hormone (PTH) in serum.

    Recall: Z-1520-2018 · Reported May 2, 2018

    Enforcement

    Recall Number
    Z-1520-2018
    Event ID
    79595
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Diagnostic Hybrids, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 2, 2018
    Initiation Date
    October 26, 2016
    Classification Date
    April 25, 2018
    Termination Date
    August 28, 2020
    Address
    2005 E State St Ste 100, N/A, Athens, OH, 45701-2125, United States

    Description

    Quidel MicroVue Intact PTH EIA, Model 8044. An enzyme immunoassay for the quantification of Intact Parathyroid Hormone (PTH) in serum.

    Reason

    There may be a loss of separation between Calibrators A and B which may impact the assay calibration at the lower end of the assay.

    Code Info

    Lot 068259

    Distribution

    The product was distributed to the following countries: Singapore, Switzerland

    Quantity

    26