BEUDAMED
    FDA Enforcement Class II Terminated

    4plus Streptavidin HRP Label, Conjugated Streptavidin Horseradish Peroxidase, Detection Component, Catalog Number: HP604H

    Recall: Z-2291-2020 · Reported June 17, 2020

    Enforcement

    Recall Number
    Z-2291-2020
    Event ID
    85359
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biocare Medical, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 17, 2020
    Initiation Date
    October 10, 2019
    Classification Date
    June 5, 2020
    Termination Date
    December 2, 2020
    Address
    60 Berry Dr, N/A, Pacheco, CA, 94553-5601, United States

    Description

    4plus Streptavidin HRP Label, Conjugated Streptavidin Horseradish Peroxidase, Detection Component, Catalog Number: HP604H

    Reason

    Firm has identified product has no staining. If used, may result in invalid test results when used with controls in the clinical setting. Positive control would observe no staining. The clinical impact may result in the consumption of patient tissue sample and a delay in diagnosis.

    Code Info

    Lot Number: 041619-4, Expiration Date: 2020/10

    Distribution

    US: TX, MA, TN, MO, IN

    Quantity

    8