BEUDAMED
    FDA Enforcement Class II Terminated

    Tina-Quant Hemoglobin A1c Gen. 2 Hemoglobin A1c test Catalog number 04528123190 / 05401640190

    Recall: Z-0395-2017 · Reported November 23, 2016

    Enforcement

    Recall Number
    Z-0395-2017
    Event ID
    75366
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Roche Diagnostics Operations, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 23, 2016
    Initiation Date
    October 4, 2016
    Classification Date
    November 11, 2016
    Termination Date
    June 5, 2017
    Address
    9115 Hague Rd, N/A, Indianapolis, IN, 46256-1025, United States

    Description

    Tina-Quant Hemoglobin A1c Gen. 2 Hemoglobin A1c test Catalog number 04528123190 / 05401640190

    Reason

    Roche Diagnostics has confirmed elevated QC and patient sample recovery for individual Tina-quant¿ Hemoglobin A1c Gen.2 and Tina-quant Hemoglobin A1cDx Gen.2 cassettes/bottles. This issue occurred over multiple lots. Single cassettes/bottles of the reagents are affected. The issue can lead to erroneously high HbA1c results. If a patient with known diabetes is affected, an erroneously high HbA1c result might lead to therapeutic consequences, such as therapy escalation (introduction of another oral antidiabetic medication or insulin) or increase of the dosage. This can further lead to an increased risk of hypoglycemia. Considering the unreliable detectability of the issue, relevant medical risk for the patient cannot entirely be excluded.

    Code Info

    Not applicable

    Distribution

    Nationwide.

    Quantity

    4976