BEUDAMED
    FDA Enforcement Class II Ongoing

    VITROS Immunodiagnostic Products Free T3 Reagent Pack-IVD is for the quantitative measurement of free triiodothyronine (FT3) in human serum and plasma (EDTA or heparin). Product Code: 131 5589

    Recall: Z-1818-2024 · Reported May 22, 2024

    Enforcement

    Recall Number
    Z-1818-2024
    Event ID
    94436
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    QUIDELORTHO
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 22, 2024
    Initiation Date
    April 9, 2024
    Classification Date
    May 14, 2024
    Address
    100 Indigo Creek Dr, N/A, Rochester, NY, 14626-5101, United States

    Description

    VITROS Immunodiagnostic Products Free T3 Reagent Pack-IVD is for the quantitative measurement of free triiodothyronine (FT3) in human serum and plasma (EDTA or heparin). Product Code: 131 5589

    Reason

    T3 Reagent Packs used with Free T3 Calibrators may produce positively biased results for patient and quality control samples. The positive bias may cause erroneous patient results or a delay in testing that may impact patient management, clinical assessment, and the results of other thyroid function tests.

    Code Info

    UDI-DI: 10758750008797 Lot Numbers: 3042 Expiry: 09-Apr-2024; 3052 Expiry: 02-May-2024; 3061 Expiry: 06-Jun-2024; 3080 Expiry: 02-May-2024; 3090 Expiry: 14-Jun-2024; 3100 Expiry: 29-Jul-2024; 3110 Expiry: 13-Aug-2024; 3126 Expiry: 04-Sep-2024

    Distribution

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

    Quantity

    21268 units