BEUDAMED
    FDA Recall Open, Classified

    epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515;

    Recall: Z-2005-2026 · Initiated April 2, 2026

    Recall

    Recall Number
    Z-2005-2026
    Event Number
    98680
    Firm
    Siemens Healthcare Diagnostics Inc
    FEI Number
    3002637618
    Product Code
    CHL
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    April 2, 2026
    Posted
    April 29, 2026
    Address
    2 Edgewater Dr, Norwood, MA, 02062-4637

    Description

    epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515;

    Reason

    Use of the affected product can result in discrepant low pH and measured Total Carbon Dioxide (mTCO2) results and corresponding calculated values in arterial, venous, and capillary patient samples. An erroneously low pH or mTCO2 reading can lead to inappropriate treatment of nonexistent acidosis (respiratory of metabolic) or missed diagnosis of alkalosis (a true high pH: respiratory or metabolic alkalosis), potentially causing harm through unnecessary interventions with the former or failure to deliver appropriate treatment with the latter.

    Action

    On April 2, 2026, Urgent Medical Device Recall letters were sent to customers. Actions to be taken: Perform the instructions provided below: " Discontinue use of and discard the kit lots listed in the table above (Products Section). " Please review this letter with your Medical Director/POC Coordinator to determine the appropriate course of action, including for any previously generated results, if applicable. " Complete and return the Field Correction Effectiveness Check Form and Product Replacement Form attached to this letter within 30 days. " Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax. " Please retain this letter with your laboratory records and forward this letter to those who may have received this product. " For any questions, you may call Siemens Healthineers Technical Solutions Center at 877- 229-3711, available daily from 7:00 AM to 11:00 PM EST.

    Distribution

    Worldwide distribution - US Nationwide and the countries of Italy, Spain, Austria, Portugal, Ireland, France, Romania, Canada, India, Philippines, Mexico.

    Quantity

    71725 (38025 US, 33700 OUS)