BEUDAMED
    FDA Recall 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 · Initiated October 26, 2016

    Recall

    Recall Number
    Z-1520-2018
    Event Number
    79595
    Firm
    Diagnostic Hybrids, Inc.
    FEI Number
    1000122536
    Product Code
    CEW
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    October 26, 2016
    Terminated
    August 28, 2020
    Address
    2005 E State St, Ste 100, Athens, OH, 45701-2125

    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.

    Action

    Customers were notified via letter and email on 10/26/16. Customers were asked to complete and return the attached response form to the recalling firm. Customers were asked to review inventory, quarantine the products with the specified lot numbers, and, if further distributed, identify and notify any additional customers.

    Distribution

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

    Quantity

    26