BEUDAMED
    FDA Recall 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 · Initiated September 11, 2019

    Recall

    Recall Number
    Z-0152-2020
    Event Number
    83806
    Firm
    Roche Diagnostics Operations, Inc.
    FEI Number
    1823260
    Product Code
    CIX
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    September 11, 2019
    Posted
    October 16, 2019
    Terminated
    June 11, 2024
    Address
    9115 Hague Rd, Indianapolis, IN, 46256-1025

    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.

    Action

    1. Discontinue use and discard the remaining affected product in your inventory according to your local waste guidelines. 2. Complete and fax or email the form even if you are not requesting product replacement. Please contact the Roche Support Network Customer Support Center 24 hours a day, seven days a week at 1-800-428-2336 if you have questions about the information contained in this UMDC. An Urgent Medical Device Correction letter dated 12/18/19 was sent to customers regarding the expansion of the recall to include an additional lot of Albumin Gen.2 Reagent. Actions Required " Discontinue use and discard the remaining affected product in your inventory according to your local waste guidelines. " Complete the attached fax form (TP-00848) and fax or email it according to the instructions on the form even if you are not requesting product replacement. " File this UMDC for future reference. Questions Please contact the Roche Support Network Customer Support Center 24 hours a day, seven days a week at 1-800-428-2336 if you have questions about the information contained in this UMDC.

    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)