BEUDAMED
    FDA Recall Open, Classified

    epoc BGEM BUN Test Card [25pk]. Material Number: 10736515.

    Recall: Z-2272-2025 · Initiated July 7, 2025

    Recall

    Recall Number
    Z-2272-2025
    Event Number
    97180
    Firm
    Siemens Healthcare Diagnostics Inc
    FEI Number
    3002637618
    Product Code
    JGS
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    July 7, 2025
    Posted
    August 5, 2025
    Address
    2 Edgewater Dr, Norwood, MA, 02062-4637

    Description

    epoc BGEM BUN Test Card [25pk]. Material Number: 10736515.

    Reason

    Siemens Healthcare Diagnostics Inc. has confirmed that a negative sodium bias may exist in some epoc test card lots. All other analytes are performing as intended. The observed average bias for sodium was -4.4 mmol/L. The maximum bias observed was -14 mmol/L, which occurred at a higher sodium concentration around 150 mmol/L. No positive bias has been observed. Quality Control (QC) fluid may or may not detect the issue depending on the bias magnitude and the frequency of QC testing.

    Action

    Siemens Healthcare Diagnostics notified consignees via letter on about 07/07/2025. Consignees were instructed to review the letter with the Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable, discard and request a replacement of any affected lots or if your institution does not need to report sodium, you can turn off sodium following the instruction of the owner s manual. Consignees were also instructed to complete and return the Field Correction Effectiveness Check Form included with letter, notify customers if products were further distributed, and to retain this letter with your laboratory records and forward this letter to those who may have received this product at your site.

    Distribution

    Worldwide distribution - US Nationwide and the countries of Argentina, Austria, Bahrain, Bolivia, Brazil, Canada, Canary Islands, Chile, Croatia, Denmark, Ecuador, Estonia, France, Fren. Polynesia, Germany, Greece, Guatemala, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Jordan, Kazakhstan, Lithuania, Malaysia, Martinique, Mexico, Morocco, Netherlands, New Caledonia, Paraguay, Philippines, Poland, Portugal, Qatar, Rep. Korea (S), Romania, Russian Fed., San Marino, Slovakia, Slovenia, South Africa, Spain, Srilanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, Uganda, Ukraine, Unit.Arab Emir., United Kingdom, Uruguay, Japan.

    Quantity

    37,554 units