BEUDAMED
    FDA Enforcement Class II Terminated

    ACCU-CHECK FastClix Lancing Device. It is intended for use in conjunction with a blood glucose monitoring system.

    Recall: Z-2109-2013 · Reported September 4, 2013

    Enforcement

    Recall Number
    Z-2109-2013
    Event ID
    65886
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Roche Diagnostics Operations, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 4, 2013
    Initiation Date
    August 19, 2013
    Classification Date
    August 28, 2013
    Termination Date
    May 12, 2014
    Address
    9115 Hague Rd, Indianapolis, IN, 46256-1025, United States

    Description

    ACCU-CHECK FastClix Lancing Device. It is intended for use in conjunction with a blood glucose monitoring system.

    Reason

    Internal Roche inspections have revealed that after the lancet is used for a finger stick, the needle may not fully retract back within the lancet drum or back into the cap. This allows the needle to protrude inside the cap or outside of the cap of the ACCU-CHEK FastClix lancing device.

    Code Info

    Lot Number(s): GDA 048, GDA050, GDA 051, GDA 063

    Distribution

    Nationwide Distribution

    Quantity

    36,332