BEUDAMED
    FDA Enforcement Class II Terminated

    ADVIA Chemistry CardioPhase High Sensitivity C-Reactive Protein (hsCRP) Calibrator - product Usage: For in vitro diagnostic use in the calibration of ADVIA¿ Chemistry systems for the CardioPhase¿ hsCRP assay.

    Recall: Z-1260-2020 · Reported February 26, 2020

    Enforcement

    Recall Number
    Z-1260-2020
    Event ID
    84413
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 26, 2020
    Initiation Date
    November 19, 2019
    Classification Date
    February 18, 2020
    Termination Date
    August 30, 2021
    Address
    511 Benedict Ave, Tarrytown, NY, 10591-5005, United States

    Description

    ADVIA Chemistry CardioPhase High Sensitivity C-Reactive Protein (hsCRP) Calibrator - product Usage: For in vitro diagnostic use in the calibration of ADVIA¿ Chemistry systems for the CardioPhase¿ hsCRP assay.

    Reason

    Atellica and ADVIA hsCRP calibrator accuracy has drifted away from the reference materials (ERM-DA470/IFCC), which is causing a high bias on QC and patient sample recovery.

    Code Info

    Siemens Material Number (SMN): ADVIA Chemistry: 10335897 REF: 05006455 Lot# 453610 Expiration Date: 2020-01 UDI Number: ADVIA: (01)00630414526843(10)453610(17)20200128

    Distribution

    Worldwide distribution  US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, NC, NE, NH, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, WA, WY and countries of UK, CA, PH, MX, VN, TW, TH, IN, CO, AE, AR, AU, BD, BE, BG, BR, CL, CZ, DE, DK, EG, ES, FI, FR, GR, HU, IE, IT, KR, MY, NL, PL, PT, RO, RU, SE, SG.

    Quantity

    844