BEUDAMED
    FDA Enforcement Class II Ongoing

    VITROS Immunodiagnostic Products Intact PTH Reagent Pack- IVD For the quantitative measurement of intact parathyroid hormone (iPTH) in human serum and plasma (EDTA or heparin) Catalog Number: 6802892

    Recall: Z-0878-2023 · Reported January 11, 2023

    Enforcement

    Recall Number
    Z-0878-2023
    Event ID
    91205
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Ortho-Clinical Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 11, 2023
    Initiation Date
    November 17, 2022
    Classification Date
    January 4, 2023
    Address
    100 Indigo Creek Dr, N/A, Rochester, NY, 14626-5101, United States

    Description

    VITROS Immunodiagnostic Products Intact PTH Reagent Pack- IVD For the quantitative measurement of intact parathyroid hormone (iPTH) in human serum and plasma (EDTA or heparin) Catalog Number: 6802892

    Reason

    Lower than expected iPTH patient and Quality Control (QC) results, reported negatively biased iPTH results- an average -12% shift in patient sample results

    Code Info

    UDI-DI: 6802892 (10758750006267) Lot Numbers/Exp Date: 1610 24-Apr-2023; 1621 24-Apr-2023; 1630 08-May-2023; 1640 08-May-2023; 1645 08-May-2023; 1650 29-May-2023; 1670 06-Jun-2023

    Distribution

    Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Bermuda DV04, Bermuda HM12, Brazil, Canada L3R 4G5, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands, United Kingdom.

    Quantity

    4,158 units