BEUDAMED
    FDA Enforcement Class II Terminated

    Cascadion SM Clinical Analyzer, REF 99990000 SN Type: 9910

    Recall: Z-1202-2021 · Reported March 17, 2021

    Enforcement

    Recall Number
    Z-1202-2021
    Event ID
    87309
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Thermo Fisher Scientific
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 17, 2021
    Initiation Date
    February 1, 2021
    Classification Date
    March 10, 2021
    Termination Date
    January 10, 2024
    Address
    Ratashe 2, Vantaa, N/A, Finland

    Description

    Cascadion SM Clinical Analyzer, REF 99990000 SN Type: 9910

    Reason

    Due to software defect, under certain assay parameters, false Vitamin D results may be reported. The system reports a false result by not quantitating the correct analyte peak in sample chromatogram. The resulting sample would show a Vitamin D-concentration that is an unusual situation for human serum and plasma samples and would indicate a severe Vitamin D deficiency.

    Code Info

    Model Number 99990000 GTIN: 06438153004925 Serial Numbers: CA100077, CA000055, CA100073, CA100074, CA000051, CA100062, CA100065, CA100069, CA100070 CA100063 CA000042, CA100071 CA100060, CA100059, CA000058, CA000053, CA000056, CA100061, CA100066

    Distribution

    U.S.: Texas O.U.S.: Belgium, France, Germany, Italy, Spain, Switzerland and United Kingdom

    Quantity

    19 systems (1 system in U.S. and 10 system O.U.S.)