BEUDAMED
    FDA Enforcement Class II Ongoing

    Atellica CH 930 Analyzer with Software version: V1.25.1 and lower- An automated, clinical chemistry analyzer designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11067000

    Recall: Z-0449-2022 · Reported January 12, 2022

    Enforcement

    Recall Number
    Z-0449-2022
    Event ID
    89160
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 12, 2022
    Initiation Date
    November 18, 2021
    Classification Date
    January 3, 2022
    Address
    511 Benedict Ave, N/A, Tarrytown, NY, 10591-5005, United States

    Description

    Atellica CH 930 Analyzer with Software version: V1.25.1 and lower- An automated, clinical chemistry analyzer designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11067000

    Reason

    (1)Software (SW) versions V1.25.1 and lower may result in TDef (Test Definition) Parameters for Open Channel Assays reverting to Default Value would shift test results by the magnitude of the implemented Assay Correlation factor; (2) On Board Stability (OBS) Not Updating with Manual Change for Open Channel Assays may continue to use the reagent past its expiration date leading to potential erroneous patient sample results

    Code Info

    Software version: V1.25.1 and lower. UDI: 00630414002163

    Distribution

    Nationwide Foreign: AU DE AE TR BG CL IN CZ BR ES KE CN PL SA BE IQ IT CW SE AR CO GR SK EE KR JP UY DK FR GB VN CA BD MX TH DZ PT RU ZA PK HU NL VA NO AT IR LV EG PH SG MY IL FI HR MA KW CH TW BH AL BF UG NZ OM HK QA PE EC IE GP LY LT

    Quantity

    2,980 units