BEUDAMED
    FDA Enforcement Class II Terminated

    ABX Pentra Micro ALBUMIN 2 CP, Serum/Plasma, REF 1300032563 The device is intended for use in conjunction with certain materials to measure a variety of analytes.

    Recall: Z-2286-2018 · Reported July 4, 2018

    Enforcement

    Recall Number
    Z-2286-2018
    Event ID
    80022
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Horiba Instruments, Inc dba Horiba Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 4, 2018
    Initiation Date
    April 26, 2018
    Classification Date
    June 25, 2018
    Termination Date
    September 26, 2019
    Address
    34 Bunsen, Irvine, CA, 92618-4210, United States

    Description

    ABX Pentra Micro ALBUMIN 2 CP, Serum/Plasma, REF 1300032563 The device is intended for use in conjunction with certain materials to measure a variety of analytes.

    Reason

    When the ABX Pentra Micro ALBUMIN 2 CP (ALBT2) Reagent 2 is sampled and dispensed immediately after an ABX Pentra Creatinine 120 CP (CREA3) Reagent 2 dispense, the final result of the microalbumin may be elevated more than 10%. This increase may affect serum, plasma and urine sample types.

    Code Info

    All lot numbers; Software Version(s): Application versions below (V5.14 & V2.12) for Pentra 400 and Versions below (V1.07) for Pentra C400

    Distribution

    Worldwide Distribution: US (nationwide) and to countries of: Bulgaria, Burma, Cameroon, Djibouti, France, Gabon, Germany, Italy, Lebanon, Mali, Mauritania, Poland, Portugal, Romania, Saudi Arabia, South Africa and Thailand.

    Quantity

    686 devices (233 devices US, 453 devices OUS)