BEUDAMED
    FDA Recall Open, Classified

    Atellica CH Urine Albumin (UAlb). Material Number: 11537225

    Recall: Z-1484-2026 · Initiated January 20, 2026

    Recall

    Recall Number
    Z-1484-2026
    Event Number
    98370
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2432235
    Product Code
    JIR
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    January 20, 2026
    Posted
    March 2, 2026
    Address
    511 Benedict Ave, Tarrytown, NY, 10591-5005

    Description

    Atellica CH Urine Albumin (UAlb). Material Number: 11537225

    Reason

    Falsely depressed UAlb patient results may occur. Affected samples with any urine albumin concentration above the UAlb measuring interval >40.0 mg/dL may report values between 6.2 mg/dL and 40.0 mg/dL.

    Action

    Siemens Healthineers notified consignees on about 01/20/2026 via mailed FedEx letter titled Urgent Medical Device Correction. Consignees were informed that as temporary mitigation, for any sample with a UAlb result above 5.0 mg/dL (50 mg/L), reanalyze the sample with a x10 dilution. If the diluted result is consistent with the initial result, either result may be reported. If the diluted result is inconsistent with the initial result, the diluted result should be reported. If you prefer to automate this dilution, please refer to your internal laboratory procedures. Consignees were instructed to review the notification with their Medical Director to determine the appropriate course of action, including evaluation of any previously generated results, if applicable, and complete and return the provided Field Correction Effectiveness Check Form. A follow-up communication will be provided when Customer Actions are no longer required.

    Distribution

    Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Brazil, Canada, Chile, Curacao,¿St¿Eus, Czech¿Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Korea, Latvia, Malaysia, Netherlands, New Zealand, Norway, Portugal, Romania, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, United¿Kingdom.

    Quantity

    4,885 units