BEUDAMED
    FDA Recall Open, Classified

    ADVIA Centaur HCY Calibrator (2 Pack). Siemens Material Number: 10310376.

    Recall: Z-1822-2025 · Initiated April 15, 2025

    Recall

    Recall Number
    Z-1822-2025
    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

    ADVIA Centaur HCY Calibrator (2 Pack). Siemens Material Number: 10310376.

    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

    1,072 packs (2,144 units) - 156 packs US, 916 packs OUS