BEUDAMED
    FDA Enforcement Class II Terminated

    Abbott i-STAT CG8+ cartridges - IVD Intended for quantitative measurement of sodium, potassium, ionized calcium, glucose, pH, pCO2, pO2 and hematocrit in venous, arterial or capillary whole blood List Number: 03P88-25

    Recall: Z-0880-2021 · Reported January 27, 2021

    Enforcement

    Recall Number
    Z-0880-2021
    Event ID
    87073
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Abbott Point Of Care Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 27, 2021
    Initiation Date
    December 22, 2020
    Classification Date
    January 19, 2021
    Termination Date
    September 1, 2023
    Address
    400 College Rd E, N/A, Princeton, NJ, 08540-6607, United States

    Description

    Abbott i-STAT CG8+ cartridges - IVD Intended for quantitative measurement of sodium, potassium, ionized calcium, glucose, pH, pCO2, pO2 and hematocrit in venous, arterial or capillary whole blood List Number: 03P88-25

    Reason

    Ionized calcium test on some i-STAT CG8+ and EG7+ cartridges may exhibit higher than expected reported results when stored at room temperature (18 to 30C) for periods of time in excess of 3 days for lot numbers *20100 to *20339 and 7 days for lot numbers *20340 and above Where * = lot letter A, K, L, M, N, W or Y.

    Code Info

    Stored at room temperature (18 to 30¿C) for periods of time in excess of: 3 days for lot numbers *20100 to *20339 7 days for lot numbers *20340 and above Where * = lot letter A, K, L, M, N, W or Y Primary GTIN (01) 00054749000163)

    Distribution

    Nationwide

    Quantity

    2,820,000 cartridges US and 2,273,453 catridges OUS