BEUDAMED
    FDA Enforcement Class II Terminated

    Microbiologics QC Sets and Panels, Gram-Positive Blood Culture Control Panel (Inactivated Pellet), Catalog # 8180 Used in test systems to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation.

    Recall: Z-0812-2020 · Reported January 22, 2020

    Enforcement

    Recall Number
    Z-0812-2020
    Event ID
    84524
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Microbiologics Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 22, 2020
    Initiation Date
    December 16, 2019
    Classification Date
    January 16, 2020
    Termination Date
    December 11, 2020
    Address
    200 Cooper Ave N, Saint Cloud, MN, 56303-4440, United States

    Description

    Microbiologics QC Sets and Panels, Gram-Positive Blood Culture Control Panel (Inactivated Pellet), Catalog # 8180 Used in test systems to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation.

    Reason

    The recommended hydration fluid for the 8180 Gram-Positive Blood Culture Control Panel (Inactivated Pellet), has changed from sterile 0.85% saline or sterile blood culture media to sterile DI water or pH 7.2 phosphate buffer.

    Code Info

    Lot # 8180-46 8180-47 8180-48 8180-49 8180-50 8180-51 8180-52

    Distribution

    Distributed nationwide including Washington DC, and distributed internationally to Germany and Netherlands.

    Quantity

    810