BEUDAMED
    FDA Enforcement Class II Ongoing

    Atellica¿ CH HDL Cholesterol- In vitro diagnostic use in the quantitative determination of HDL cholesterol in human serum and plasma (lithium heparin, EDTA, sodium Heparin) Test Code: HDLC Siemens Material Number (SMN): 11537213

    Recall: Z-2474-2023 · Reported September 6, 2023

    Enforcement

    Recall Number
    Z-2474-2023
    Event ID
    92800
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 6, 2023
    Initiation Date
    July 10, 2023
    Classification Date
    August 28, 2023
    Address
    511 Benedict Ave, N/A, Tarrytown, NY, 10591-5005, United States

    Description

    Atellica¿ CH HDL Cholesterol- In vitro diagnostic use in the quantitative determination of HDL cholesterol in human serum and plasma (lithium heparin, EDTA, sodium Heparin) Test Code: HDLC Siemens Material Number (SMN): 11537213

    Reason

    Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could impact quality control (QC), patient samples, and calibrator results with from Atellica¿ CH Total Bilirubin_2 (TBil_2), Atellica¿ CH LDL Cholesterol (LDLC), Atellica¿ CH Gamma-Glutamyl Transferase (GGT) and Atellica CH HDL Cholesterol (HDLC)

    Code Info

    Unique Device Identification (UDI): 00630414610832 All lot numbers

    Distribution

    US Nationwide - Worldwide Distribution Foreign: Taiwan Uruguay Vietnam

    Quantity

    18524 units