BEUDAMED
    FDA Enforcement Class III Terminated

    Roche Diagnostics cobas Integra Albumin Gen.2 Catalog Number: 05166861190 - Product Usage: In vitro test for the quantitative determination of the albumin in human serum and plasma on Roche/Hitachi cobas c systems.

    Recall: Z-0152-2020 · Reported October 23, 2019

    Enforcement

    Recall Number
    Z-0152-2020
    Event ID
    83806
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Roche Diagnostics Operations, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 23, 2019
    Initiation Date
    September 11, 2019
    Classification Date
    October 16, 2019
    Termination Date
    June 11, 2024
    Address
    9115 Hague Rd, N/A, Indianapolis, IN, 46256-1025, United States

    Description

    Roche Diagnostics cobas Integra Albumin Gen.2 Catalog Number: 05166861190 - Product Usage: In vitro test for the quantitative determination of the albumin in human serum and plasma on Roche/Hitachi cobas c systems.

    Reason

    Due to low Quality Control recovery and invalid Calibration.

    Code Info

    Lot # 33962301. Expanded on 12/20/19 to include lot 37437301

    Distribution

    US Nationwide distribution including the states of AL, AZ, CA, CT, FL, GA, HI, IA, IL, IN, KY, LA, MA, MD, MI, MO, NE, NH, NJ, NY, OH, OK, PA, PR, RI, SC, TN, TX, UT, VA and WI. Updated as of 12/20/19 to include the following additional US states: CO.

    Quantity

    7,032 units (Expanded on 12/20/19 to include 29,696 additional units)