BEUDAMED
    FDA Enforcement Class III Terminated

    Albumin Gen.2, Catalog 05166861190

    Recall: Z-0104-2021 · Reported October 21, 2020

    Enforcement

    Recall Number
    Z-0104-2021
    Event ID
    86406
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Roche Diagnostics Operations, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    N/A
    Report Date
    October 21, 2020
    Initiation Date
    August 27, 2020
    Classification Date
    October 13, 2020
    Termination Date
    May 22, 2024
    Address
    9115 Hague Rd, N/A, Indianapolis, IN, 46256-1025, United States

    Description

    Albumin Gen.2, Catalog 05166861190

    Reason

    Roche has confirmed customer complaints of low quality (QC) recovery and invalid calibrations for the identified products. A discoloration (yellow color) was observed and is the result of cross contamination between the R1 and R3 reagents.

    Code Info

    lots 43031001, 43718901

    Distribution

    Domestic distribution nationwide.

    Quantity

    11963