BEUDAMED
    FDA Recall Open, Classified

    Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro diagnostic test for group b streptococcus.

    Recall: Z-0877-2022 · Initiated March 18, 2022

    Recall

    Recall Number
    Z-0877-2022
    Event Number
    89855
    Firm
    Hologic, Inc
    FEI Number
    2024800
    Product Code
    NJR
    Status
    Open, Classified
    Root Cause
    Component change control
    Initiated
    March 18, 2022
    Posted
    April 6, 2022
    Address
    10210 Genetic Center Dr, San Diego, CA, 92121-4362

    Description

    Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro diagnostic test for group b streptococcus.

    Reason

    Samples, run on a GBS Assay, that have analyte concentrations that are at or near the limit of detection may produce false negative results.

    Action

    On 03/18/22, recall notices were sent to customers who were informed that the recalling firm is discontinuing the further sale of the affected GBS Assay for the foreseeable future. Customers were asked to do the following: 1) Discontinue use and destroy affected GBS assay kit lots and respective components. 2) Complete and return the customer response form. Customers with additional questions were encouraged to contact Technical Support at +1 888 484 4747 or +1 858 410 8511 between 5am PDT and 5 pm PDT, or by email at [email protected]

    Distribution

    US: TX, TN, NY, NV, IN, AR, CA, CT, IL, NH, PA, WA, FL, OR, WV, VA, UT, MA, NJ, MI, PR OUS: CA

    Quantity

    2061