BEUDAMED
    FDA Enforcement Class II Ongoing

    Atellica IM Homocysteine Calibrator (2 Pack). Siemens Material Number: 10995498

    Recall: Z-1821-2025 · Reported June 4, 2025

    Enforcement

    Recall Number
    Z-1821-2025
    Event ID
    96693
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 4, 2025
    Initiation Date
    April 15, 2025
    Classification Date
    May 27, 2025
    Address
    333 Coney St, N/A, East Walpole, MA, 02032-1516, United States

    Description

    Atellica IM Homocysteine Calibrator (2 Pack). Siemens Material Number: 10995498

    Reason

    Certain lots of Atellica IM Homocysteine Calibrator and ADVIA Centaur HCY Calibrator do not meet the assay Instructions for Use (IFU) reference interval due to calibrator instability resulting in increased positive bias.

    Code Info

    Siemens Material Number: 10995498. UDI Number: (01)00630414598253(10)86236A74(17)20250514, (01)00630414598253(10)44206A75(17)20250925. Kit lot numbers: 86236A74, 44206A75.

    Distribution

    Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KY, MA, MD, ME, MI, MO, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, TX, UT, VA, VT, WI, WY and the countries of Austria, Belgium, Croatia, Curacao,¿St¿Eus, Czech¿Republic, Denmark, Egypt, Finland, France, Georgia, Germany, Greece, Hungary, Iran, Ireland, Israel, Italy, Jordan, Kuwait, Latvia, Lithuania, Nepal, Netherlands, Norway, Pakistan, Poland, Portugal, Romania, Serbia, Slovakia, Spain, Sweden, Switzerland, Turkey, Turkmenistan, U.A.E., United¿Kingdom, Vatikan City, Zaire.

    Quantity

    2,212 packs (4,424 units) - 448 packs US, 1,764 packs OUS