BEUDAMED
    FDA Recall 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 · Initiated December 16, 2019

    Recall

    Recall Number
    Z-0812-2020
    Event Number
    84524
    Firm
    Microbiologics Inc
    FEI Number
    2150138
    Product Code
    OHQ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    December 16, 2019
    Terminated
    December 11, 2020
    Address
    200 Cooper Ave N, Saint Cloud, MN, 56303-4440

    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.

    Action

    Recall Letters was sent via email to all consignees regarding the correction on 12/16/2019 informing users of a new recommended hydration fluid which is reflected in labeling QC Sets and Panels: Technical Information TIB.2034 Rev G. Questions can be directed at Technical Support team at 1.320.229.7064 or [email protected] . A response form is requested to be returned.

    Distribution

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

    Quantity

    810