BEUDAMED
    FDA Enforcement Class II Terminated

    The Tina-quant lgA Gen.2 is an immunoturbidimetric assay. Anti-lgA antibodies react with antigen in the sample to form an antigen/antibody complex which is measured turbidimetrically.

    Recall: Z-1979-2019 · Reported July 24, 2019

    Enforcement

    Recall Number
    Z-1979-2019
    Event ID
    83095
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Roche Diagnostics Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 24, 2019
    Initiation Date
    June 3, 2019
    Classification Date
    July 16, 2019
    Termination Date
    August 28, 2020
    Address
    9115 Hague Rd, N/A, Indianapolis, IN, 46256-1025, United States

    Description

    The Tina-quant lgA Gen.2 is an immunoturbidimetric assay. Anti-lgA antibodies react with antigen in the sample to form an antigen/antibody complex which is measured turbidimetrically.

    Reason

    Calibration failures with Std.E, Sens.E, or Dup.E error due to atypical reaction kinetics and quality control failures have occurred due to contamination of R1 reagent with R3 reagent.

    Code Info

    Lot 368756

    Distribution

    The products were distributed to the following US states: AL, IN, and KY.

    Quantity

    8 units