BEUDAMED
    FDA Recall Open, Classified

    VITROS Chemistry Products VersaTips, Catalog No. 6801715 A VersaTip sales unit is composed of 1000 tips per box.

    Recall: Z-0735-2022 · Initiated December 10, 2021

    Recall

    Recall Number
    Z-0735-2022
    Event Number
    89362
    Firm
    Ortho-Clinical Diagnostics, Inc.
    FEI Number
    1000136573
    Product Code
    JRC
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    December 10, 2021
    Address
    100 Indigo Creek Dr, Rochester, NY, 14626-5101

    Description

    VITROS Chemistry Products VersaTips, Catalog No. 6801715 A VersaTip sales unit is composed of 1000 tips per box.

    Reason

    The lot has a shape deformity which may lead to a 16% reduction in the volume of the sample or reagent dispensed. In cases where the error is not detected and the affected results are not suppressed, clinical impact may include reduced drug dosage, or false positive or false negative results for bloodborne infectious disease assays when sample results are close to the cut-off value.

    Action

    On December 10, 2021, the firm notified consignees through ORTHO PLUSSM (a service that provides customers with Ortho Clinical Diagnostics product notifications electronically) of the product issue. Customers were instructed to discontinue use and discard the affected lot. Customers should forward the notification if the product was distributed outside of their facility.

    Distribution

    Domestic distribution nationwide. Foreign distribution to Canada.

    Quantity

    4125 units