BEUDAMED
    FDA Enforcement Class II Ongoing

    STAT-Site M BHB Test Strips, used with STAT-SITE M Beta-HB Meter as an in vitro diagnostic for blood ketone values.

    Recall: Z-0490-2024 · Reported December 13, 2023

    Enforcement

    Recall Number
    Z-0490-2024
    Event ID
    93300
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Stanbio Laboratory, LP
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 13, 2023
    Initiation Date
    October 2, 2023
    Classification Date
    December 6, 2023
    Address
    1261 N Main St, Boerne, TX, 78006-3014, United States

    Description

    STAT-Site M BHB Test Strips, used with STAT-SITE M Beta-HB Meter as an in vitro diagnostic for blood ketone values.

    Reason

    Deterioration in the stability of the Test Strips results in diminished low-range detection capability and inability to meet linearity performance claims. The root cause of the stability deterioration in is identified as the change in material that caused a pH shift in the coating solution resulting in precipitation during coating runs. The device defect can cause false negative results that may lead to a delay in treatment of patients with associated conditions such as diabetic ketoacidosis.

    Code Info

    UDI-DI: 00657498000090, Lot/Expiration: 203044/2024-01-31, 209644/2024-06-30

    Distribution

    Worldwide - US Nationwide distribution including in the states of AZ, RI, MO, UT, AK, LA, TX, OH, GA, MN, NY, CA, NJ, IL, WA, KS, MI, NC, PA, MA, CO, KY, NM, FL, MD, VA, IN, AL, SD, MS, WV, WI, ID, MT, WY and the countries of Canada and Singapore.

    Quantity

    2,351