BEUDAMED
    FDA Enforcement Class II Ongoing

    RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097.

    Recall: Z-2230-2025 · Reported August 6, 2025

    Enforcement

    Recall Number
    Z-2230-2025
    Event ID
    97209
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 6, 2025
    Initiation Date
    June 26, 2025
    Classification Date
    July 31, 2025
    Address
    2 Edgewater Dr, Norwood, MA, 02062-4637, United States

    Description

    RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097.

    Reason

    Siemens Healthcare Diagnostics is recalling the RAPIDPoint 500 Systems Wash/Waste Cartridge Lot WW/08925 due to a manufacturing error causing positive and negative bias in Ionized Calcium, Potassium, pH, Chloride, pCO2, Glucose and Lactate analytes and their derivatives. Four complaints were filed related to this event that led to Siemens Healthcare Diagnostics identifying an error in the manufacturing process and initiated corrective actions. Use of the affected device may result in errors during QC which could lead to a delay in patient treatment. If bias generated from this issue is not caught during QC erroneous results may cause temporary or medically reversible adverse health consequences to patients.

    Code Info

    Material Number: 10329097. GTIN Number: 00630414482163. Lot Number: WW/08925. Expiration Date: 12/03/2025.

    Distribution

    worldwide distribution - US Nationwide and the countries of Canada, Chile, Japan, Paraguay.

    Quantity

    1,477 units