BEUDAMED
    FDA Enforcement Class II Ongoing

    DCA Systems HbA1c Reagent Kit

    Recall: Z-1304-2024 · Reported March 27, 2024

    Enforcement

    Recall Number
    Z-1304-2024
    Event ID
    94021
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 27, 2024
    Initiation Date
    February 7, 2024
    Classification Date
    March 19, 2024
    Address
    511 Benedict Ave, Tarrytown, NY, 10591-5005, United States

    Description

    DCA Systems HbA1c Reagent Kit

    Reason

    The reason for the recall is that the Siemens DCA HbA1c Reagent Kit was confirmed to display a positive bias without alerting the user. The potential impact of the defect is that erroneous test results could be reported and potentially lead to incorrect patient management of glucose control. A positive bias may be observed with eleven HbA1c affected lots. Positive bias was observed when the performance of these five HbA1c lots was compared to NGSP pooled patient target-value assigned samples and the maximum bias observed was 19%.

    Code Info

    Siemens Material Number: 10311134; UDI/DI: 00630414532806; Lot#: 9640093, 0645103, 0648103, 0649103, 0654103 . Expanded Lots (02/28/2024): 0637093, 0641093, 0642093, 0647103, 0653103, 0655103;

    Distribution

    Worldwide distribution - US Nationwide and the country of Taiwan.

    Quantity

    74,211 Kits (Expanded 2/28/24: additional 72,892 kits)