BEUDAMED
    FDA Enforcement Class II Terminated

    Randox Cholesterol- For the quantitative in vitro determination of Cholesterol in serum and plasma. Catalog Number: CH2O0

    Recall: Z-1424-2022 · Reported July 27, 2022

    Enforcement

    Recall Number
    Z-1424-2022
    Event ID
    90522
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Randox Laboratories Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 27, 2022
    Initiation Date
    June 22, 2022
    Classification Date
    July 20, 2022
    Termination Date
    May 10, 2024
    Address
    55 Diamond Road, N/A, Crumlin (North), N/A, N/A, Ireland

    Description

    Randox Cholesterol- For the quantitative in vitro determination of Cholesterol in serum and plasma. Catalog Number: CH2O0

    Reason

    Product fails to meet the performance claims quoted on the kit insert: Manual Procedure when calibrating using the standard provided in the kit, the change in absorbance is lower than expected generating internal quality control results high outside range; Cholesterol (CHOL) Instrument Specific Application using the recommended calibration material CAL2351, the product fails to meet its linearity performance claim quoted on the kit inserts. The linearity is reduced by up to -35% however Quality Control results will still fall within assigned ranges. This may lead to delayed results.

    Code Info

    GTIN : 05055273201130 Lot Number: 586177 Expiry Date: 28th Jan 2024

    Distribution

    Nationwide Distribution - MD, OR, PR, MT, WV

    Quantity

    15 kits