BEUDAMED
    FDA Recall 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 · Initiated April 18, 2017

    Recall

    Recall Number
    Z-2591-2018
    Event Number
    80321
    Firm
    ELITech Clinical Systems SAS Zone Industrielle des Fourneaux Sees France
    FEI Number
    3007662974
    Product Code
    JIX
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    April 18, 2017
    Terminated
    April 17, 2020

    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.

    Action

    ELITech Clinical Systems SAS notified consignees on April 18, 2018 via USPS certified letter, dated April 10, 2018 titled Product Recall Notice. The Product Recall Notice provided customers/consignees reason for recall, actions to be taken, and included a confirmation of receipt of product recall notice form to be filled out and returned by customer/consignee.

    Distribution

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