BEUDAMED
    FDA Enforcement Class II Ongoing

    The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 (or DM) Analyzer with plasma conversion that multiplies the measured whole blood glucose value by a factor of 1.112 and displays a plasma equivalent glucose result. HemoCue Glucose 201 Microcuvettes are available in individual packages or in vials. The box contains 4 vials with 25 microcuvettes in each vial.

    Recall: Z-2070-2025 · Reported July 9, 2025

    Enforcement

    Recall Number
    Z-2070-2025
    Event ID
    97025
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    HemoCue AB
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 9, 2025
    Initiation Date
    May 12, 2025
    Classification Date
    July 2, 2025
    Address
    Kuvettgatan 1, Angelholm, N/A, Sweden

    Description

    The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 (or DM) Analyzer with plasma conversion that multiplies the measured whole blood glucose value by a factor of 1.112 and displays a plasma equivalent glucose result. HemoCue Glucose 201 Microcuvettes are available in individual packages or in vials. The box contains 4 vials with 25 microcuvettes in each vial.

    Reason

    Glucose microcuvettes experienced transit time outside of limits, so stability through the whole microcuvette lifetime can no longer be guaranteed. The affected products may not have been stored at the recommended labeled storage conditions which may have impacted the safety, quality, identity, potency, and purity of the product. This failure could increase the probability of an incorrect test result or a delayed test result.

    Code Info

    UDI-DI: 07311091107060, Lot: 2501708 (Only 4 boxes within specific McKesson Shipment)

    Distribution

    US Nationwide distribution in the state of AR.

    Quantity

    4 Boxes