BEUDAMED
    FDA Enforcement Class II Terminated

    Lactate Dehydrogenase L-P, (LDH) (NAO), Catalog Number LD3842 - Product Usage: device intended for the quantitative in vitro determination of Lactate Dehydrogenase (LD) activity in serum and plasma. This product is suitable for use on the RX series instruments which includes the RX daytona and RX imola.

    Recall: Z-2962-2020 · Reported September 23, 2020

    Enforcement

    Recall Number
    Z-2962-2020
    Event ID
    86236
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Randox Laboratories Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 23, 2020
    Initiation Date
    August 11, 2020
    Classification Date
    September 11, 2020
    Termination Date
    October 15, 2020
    Address
    55 Diamond Road, N/A, Crumlin (North), N/A, N/A, Ireland

    Description

    Lactate Dehydrogenase L-P, (LDH) (NAO), Catalog Number LD3842 - Product Usage: device intended for the quantitative in vitro determination of Lactate Dehydrogenase (LD) activity in serum and plasma. This product is suitable for use on the RX series instruments which includes the RX daytona and RX imola.

    Reason

    An update to the carryover avoidance technical bulletin to introduce additional steps for reagent carryover avoidance with the Lactate Dehydrogenase assay on RX Instruments. Additional pipette washes can be implemented as described in the technical bulletin. Interference to the Lactate Dehydrogenase (LOH) reagent would be observed as inconsistencies in Quality Control recovery, which may lead to a delay in running patient samples, or erroneous elevated test results.

    Code Info

    GTIN: 05055273204124; Lot Numbers: 480483 495947 523902 536342

    Distribution

    US Nationwide distribution including in the states of WV, and Puerto Rico.

    Quantity

    21