BEUDAMED
    FDA Enforcement Class II Terminated

    i-STAT G3+ cartridge (blue), List No. 03P78-50, UDI (01) 00054749002283 - Product Usage: The i-STAT G3+ cartridge may be used for the quantitative measurement of pH, pCO2, and pO2 in venous, arterial or capillary whole blood.

    Recall: Z-1265-2020 · Reported February 26, 2020

    Enforcement

    Recall Number
    Z-1265-2020
    Event ID
    84730
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Abbott Point Of Care Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    February 26, 2020
    Initiation Date
    January 14, 2020
    Classification Date
    February 18, 2020
    Termination Date
    April 12, 2021
    Address
    400 College Rd E, Princeton, NJ, 08540-6607, United States

    Description

    i-STAT G3+ cartridge (blue), List No. 03P78-50, UDI (01) 00054749002283 - Product Usage: The i-STAT G3+ cartridge may be used for the quantitative measurement of pH, pCO2, and pO2 in venous, arterial or capillary whole blood.

    Reason

    Marketed without a 510(k). Abbott Point of Care has determined that it does not have sufficient clinical evidence to fully characterize the performance of the blue i-STAT G3+ cartridges and therefore will no longer distribute the i-STAT G3+ (blue) cartridge in the United States as of May 1, 2020.

    Code Info

    All lots are affected

    Distribution

    US Nationwide distribution.

    Quantity

    4,448,525