BEUDAMED
    FDA Enforcement Class II Terminated

    Randox Blood Gas Control Level 2 -Model BG5002. In-vitro Diagnostic Quality control of Blood Gas analysis This product is intended for in vitro diagnostic use, in the quality control of Blood Gas analysis. Target values and ranges are supplied for the following analytes: Calcium, Chloride, Glucose, Lactate, PCO2, pH, pO2, Potassium, Sodium and Total CO2.

    Recall: Z-1057-2019 · Reported April 3, 2019

    Enforcement

    Recall Number
    Z-1057-2019
    Event ID
    82195
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Randox Laboratories Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 3, 2019
    Initiation Date
    February 13, 2019
    Classification Date
    March 26, 2019
    Termination Date
    April 14, 2020
    Address
    55 Diamond Road, N/A, Crumlin (North), N/A, N/A, Ireland

    Description

    Randox Blood Gas Control Level 2 -Model BG5002. In-vitro Diagnostic Quality control of Blood Gas analysis This product is intended for in vitro diagnostic use, in the quality control of Blood Gas analysis. Target values and ranges are supplied for the following analytes: Calcium, Chloride, Glucose, Lactate, PCO2, pH, pO2, Potassium, Sodium and Total CO2.

    Reason

    An error in the assignment of the control range pH in Blood Gas Control

    Code Info

    Lot Code: 184BG GTIN: 05055273227116

    Distribution

    US Distribution to state of: WV

    Quantity

    1 kit