BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-1821-2025 · Initiated April 15, 2025

    Recall

    Recall Number
    Z-1821-2025
    Event Number
    96693
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    1219913
    Product Code
    JIS
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    April 15, 2025
    Posted
    May 27, 2025
    Address
    333 Coney St, East Walpole, MA, 02032-1516

    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.

    Action

    An Urgent Medical Device Correction (UMDC) was mailed to all US affected customers by FedEx, and an Urgent Field Safety Notice (UFSN) was issued to all OUS Siemens reporting sites with affected customers on about 04/15/2025. Customers were instructed to review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, discontinue use of and discard the affected devices, and complete and return the Effectiveness Check questionnaire. Customers were also instructed to forward the letter to those who may have received the affected devices.

    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