BEUDAMED
    FDA Recall Open, Classified

    Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536;

    Recall: Z-1657-2026 · Initiated February 23, 2026

    Recall

    Recall Number
    Z-1657-2026
    Event Number
    98498
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2432235
    Product Code
    PDJ
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    February 23, 2026
    Posted
    March 27, 2026
    Address
    511 Benedict Ave, Tarrytown, NY, 10591-5005

    Description

    Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536;

    Reason

    A potential for depressed results for Atellica CH A1c_E when processing Atellica CH RCRP on the same analyzer. Customers processing A1c_E and RCRP on separate analyzers are not impacted by the recall. The frequency and magnitude of the negative bias and imprecision increase over time and are not consistent with the assay Instructions For Use (IFU). When this issue is present, Quality Control (QC) results demonstrate a negative trend and increased imprecision. The clinical impact of a negative (A1c_E) bias may lead to a delay in diagnosis for diabetes or lead to less-than-optimal treatment for existing diabetes.

    Action

    On February 23, 2026 Urgent Medical Device Correction letters were sent to customers. Actions required: If your laboratory is not processing RCRP and A1c_E on the same analyzer, no action is required. If your laboratory is processing RCRP and A1c_E on the same analyzer, monitor A1c_E QC for evidence of negative bias and increased imprecision. Please review this letter with your Medical Director to determine the appropriate course of action, including evaluation of any previously generated results, if applicable. Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. Retain this letter with your laboratory records and forward it to others who may have received this product. Resolution A follow-up communication will be provided when Customer Actions are no longer required. We appreciate your continued partnership and apologize for any inconvenience this situation may cause. If you have any questions or require assistance, please contact your Siemens Healthineers Customer Care Center or your local technical support representative.

    Distribution

    Domestic: Nationwide Distribution International: Argentina, Australia, Bangladesh, Brazil, Bulgaria , Canada, Chile, China, Colombia, Croatia , Cura¿ao, St Eus, Czech Republic , Denmark , Ecuador, Egypt , Estonia , Finland , France , Georgia , Germany , Greece , Hong Kong, India, Iraq , Italy , Jordan , Kuwait , Latvia , Lithuania , Macedonia , Malaysia, Maldives, Mexico, Netherlands , New Zealand, Norway , Oman , Pakistan , Paraguay, Qatar , Romania , Saudi Arabia , Serbia , Singapore, Slovakia , Slovenia , South Africa, South Korea, Spain , Turkey , Turkmenistan , U.A.E. , Uganda , United Kingdom , Uruguay , Vatikancity;

    Quantity

    21,291 units (9750 US, 11541 OUS)