BEUDAMED
    FDA Enforcement Class II Terminated

    ENVOY 500 ISE CALIBRATOR KIT, reference 55117 (contained 6 x 20 mL Calibrator High level and 6 x 20 mL Calibrator Low level). Model/Catalog Number: 55117

    Recall: Z-2591-2018 · Reported August 8, 2018

    Enforcement

    Recall Number
    Z-2591-2018
    Event ID
    80321
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    ELITech Clinical Systems SAS
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 8, 2018
    Initiation Date
    April 18, 2017
    Classification Date
    August 1, 2018
    Termination Date
    April 17, 2020
    Address
    Zone Industrielle des Fourneaux, N/A, Sees, N/A, N/A, France

    Description

    ENVOY 500 ISE CALIBRATOR KIT, reference 55117 (contained 6 x 20 mL Calibrator High level and 6 x 20 mL Calibrator Low level). Model/Catalog Number: 55117

    Reason

    ELITech Clinical Systems SAS initiated this recall because some users of ENVOY 500 ISE CALIBRATOR Kit (Part number: 55117), for Envoy 500 systems are observing trouble while calibrating with some vials. Users contacted the firm when they received the messages "ISE OUT OF REPRODUCIBILITY" or "ISE SLOPE OUT OF RANGE" (i.e., failed calibration). This has resulted in delay in obtaining patient results until the calibrator lot is replaced.

    Code Info

    Lot number 7038 , Manufacture date 03/2017, Expiration date 02/2019

    Distribution

    U.S. only. No gov. accounts. No international.

    Quantity

    N/A