BEUDAMED
    FDA Enforcement Class II Terminated

    Vital Diagnostics Envoy Calcium Reagent For In-Vitro Diagnostic Use. PN 55285 For the quantitative measurement of calcium in plasma and serum

    Recall: Z-0732-2014 · Reported January 22, 2014

    Enforcement

    Recall Number
    Z-0732-2014
    Event ID
    66202
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Vital Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 22, 2014
    Initiation Date
    August 29, 2013
    Classification Date
    January 14, 2014
    Termination Date
    August 26, 2015
    Address
    27 Wellington Rd, Lincoln, RI, 02865-4411, United States

    Description

    Vital Diagnostics Envoy Calcium Reagent For In-Vitro Diagnostic Use. PN 55285 For the quantitative measurement of calcium in plasma and serum

    Reason

    High positive calcium bias on plasma sample versus results on serum

    Code Info

    All lots

    Distribution

    Nationwide Distribution

    Quantity

    395 units