BEUDAMED
    FDA Recall Open, Classified

    Magnesium Flex reagent cartridge, 360 tests, Catalog Number: K3057; Siemens Material Number (SMN): 10445158;

    Recall: Z-0767-2025 · Initiated November 12, 2024

    Recall

    Recall Number
    Z-0767-2025
    Event Number
    95751
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2517506
    Product Code
    JGJ
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    November 12, 2024
    Posted
    December 26, 2024
    Address
    500 Gbc Dr, Newark, DE, 19702-2466

    Description

    Magnesium Flex reagent cartridge, 360 tests, Catalog Number: K3057; Siemens Material Number (SMN): 10445158;

    Reason

    Siemens Healthcare Diagnostics is recalling two lots of their Dimension Vista Total Magnesium (MG) Flex Reagent Cartridges (lots 24057BB and 24064BC) due to the potential for falsely low measurements of magnesium in plasma. Because the error is intermittent, existing quality control procedures may not recognize that a patients results are incorrect, and the results may be reported out

    Action

    On November 12, 2024 URGENT MEDICAL DEVICE CORRECTION letters were sent to consignees. Customer Actions Please review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable. Discontinue use of and discard the lots listed above. Review your inventory of these products to determine your laboratory s replacement needs and to provide information to Siemens Healthineers for reporting to the authorities. Complete and return the Field Correction Effectiveness Check Form attached to this letter within thirty (30) days. Please retain this letter with your laboratory records and forward this letter to those who may have received the product. Resolution Siemens Healthineers has introduced additional manufacturing process controls that have resolved this issue. We apologize for the inconvenience this situation may cause. If you have any questions, please contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative.

    Distribution

    Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Denmark, France, Germany, Italy, Slovenia, Spain.

    Quantity

    13,115 units (11,520 US, 1,595 ROW)