BEUDAMED
    FDA Enforcement Class II Terminated

    Albumin BCP Product Usage: ALBP is an in vitro test used for the quantitative determination of albumin in human serum and plasma on Roche/Hitachi cobas c systems.

    Recall: Z-1194-2019 · Reported April 24, 2019

    Enforcement

    Recall Number
    Z-1194-2019
    Event ID
    82388
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Roche Diagnostics Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 24, 2019
    Initiation Date
    March 18, 2019
    Classification Date
    April 18, 2019
    Termination Date
    August 28, 2020
    Address
    9115 Hague Rd, N/A, Indianapolis, IN, 46256-1025, United States

    Description

    Albumin BCP Product Usage: ALBP is an in vitro test used for the quantitative determination of albumin in human serum and plasma on Roche/Hitachi cobas c systems.

    Reason

    The reagent lot is exhibiting calibration failures, QC imprecision, and elevated QC recovery due to elevated pH level causing higher absorbance values.

    Code Info

    Catalog Number 05975573190 Lot Number 35651401

    Distribution

    US Nationwide distribution in the states of: GA, IL, KY, MI, and TX.

    Quantity

    774