BEUDAMED
    FDA Enforcement Class II Ongoing

    Atellica IM Cortisol 50T (Material Number 10995538), 250T (Material Number 10995537), and REF 250T (Material Number 11206248). In vitro diagnostic use in the quantitative determination of cortisol in human serum, plasma (EDTA and lithium heparin), and urine.

    Recall: Z-1504-2023 · Reported May 10, 2023

    Enforcement

    Recall Number
    Z-1504-2023
    Event ID
    92059
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 10, 2023
    Initiation Date
    March 16, 2023
    Classification Date
    May 3, 2023
    Address
    511 Benedict Ave, Tarrytown, NY, 10591-5005, United States

    Description

    Atellica IM Cortisol 50T (Material Number 10995538), 250T (Material Number 10995537), and REF 250T (Material Number 11206248). In vitro diagnostic use in the quantitative determination of cortisol in human serum, plasma (EDTA and lithium heparin), and urine.

    Reason

    There is a negative bias with urine patient samples and urine cortisol Quality Control (QC) results intermittently out of range low.

    Code Info

    Atellica IM Cortisol (50T) UDI-DI: 00630414598659; Kit Lot Numbers: 50732343 50733343 88975345 29106347 29107347 and higher; Atellica IM Cortisol 250T UDI-DI: 00630414598642; Kit Lot Numbers: 50734343 88974345 29105347 and higher; Atellica IM Cortisol (REF) 250T UDI-DI: 00630414293608; Kit Lot Numbers: 53842343 58039343 94430345 and higher

    Distribution

    Worldwide distribution - US Nationwide.

    Quantity

    34,746 kits