BEUDAMED
    FDA Enforcement Class II Terminated

    Dimension Vista Lactate Dehydrogenase (LDI) Flex reagent cartridge, an in vitro diagnostic test for the quantitative measurement of lactate dehydrogenase in human serum and plasma on the Dimension Vista¿ System.Cat. No. K2054, Mat. No. 10464323

    Recall: Z-0499-2019 · Reported December 5, 2018

    Enforcement

    Recall Number
    Z-0499-2019
    Event ID
    81433
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 5, 2018
    Initiation Date
    October 11, 2018
    Classification Date
    November 27, 2018
    Termination Date
    June 29, 2020
    Address
    500 Gbc Dr Ms 514, N/A, Newark, DE, 19702-2466, United States

    Description

    Dimension Vista Lactate Dehydrogenase (LDI) Flex reagent cartridge, an in vitro diagnostic test for the quantitative measurement of lactate dehydrogenase in human serum and plasma on the Dimension Vista¿ System.Cat. No. K2054, Mat. No. 10464323

    Reason

    Siemens Healthcare Diagnostics has confirmed that Dimension Vista Lactate Dehydrogenase (LDI) may exhibit an erroneously elevated result when the preceding assay in the reaction cuvette is Lactic Acid (LA). The magnitude of the elevation may be variable. Both quality control and patient samples may be impacted. Incomplete removal of residual lactate dehydrogenase, a component of the LA reagent, has been identified as the cause of the potentially elevated result. A falsely elevated result for lactate dehydrogenase may lead to additional investigations to determine the etiology of tissue damage. Results would be correlated with clinical history and presentation in addition to other diagnostic laboratory testing.

    Code Info

    18240BA 18199BA 18162AC 18155BB 18106BC 18073BE 18036BC 17342BA

    Distribution

    Worldwide-domestic nationwide and foreign distribution.

    Quantity

    13435