BEUDAMED
    FDA Enforcement Class II Terminated

    Strep B Carrot Broth One-Step, 16x100mm Tube, 6ml, Item code Z46BX - Product Usage: Intended to detect Group B Streptococcus (GBS) from anovaginal specimen collected from pregnant women. If pregnant woman is positive for GBS colonization, this will indicate a need for treatment prior to vaginal delivery in order to prevent infection of the neonate.

    Recall: Z-2051-2020 · Reported May 27, 2020

    Enforcement

    Recall Number
    Z-2051-2020
    Event ID
    85509
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cardinal Health Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 27, 2020
    Initiation Date
    April 20, 2020
    Classification Date
    May 20, 2020
    Termination Date
    July 23, 2020
    Address
    7000 Cardinal Pl, N/A, Dublin, OH, 43017-1091, United States

    Description

    Strep B Carrot Broth One-Step, 16x100mm Tube, 6ml, Item code Z46BX - Product Usage: Intended to detect Group B Streptococcus (GBS) from anovaginal specimen collected from pregnant women. If pregnant woman is positive for GBS colonization, this will indicate a need for treatment prior to vaginal delivery in order to prevent infection of the neonate.

    Reason

    Three products requiring refrigerated storage conditions were incorrectly stored outside of approved temperature ranges. Using these temperature abused products may result in misdiagnosis of the patient.

    Code Info

    All lots

    Distribution

    US Nationwide distribution NC, KS, and AL.

    Quantity

    N/A