BEUDAMED
    FDA Recall 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 · Initiated October 11, 2018

    Recall

    Recall Number
    Z-0499-2019
    Event Number
    81433
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2517506
    Product Code
    CFJ
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    October 11, 2018
    Terminated
    June 29, 2020
    Address
    500 Gbc Dr Ms 514, Newark, DE, 19702-2466

    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.

    Action

    An Urgent Medical Device Correction were issued on October 11, 2018 to all Dimension Vista customers to notify them of the issue, the potential risk to health, and actions to be taken by the customer. Customers were instructed to: -Configure Dimension Vista System to eliminate the potential for cuvette carryover from lactic acid. -If unable to separate the assays due to lack of additional server based on the the Dimension Vista model, run Lactate Dehydrogenase method in duplicates and contact Siemens if either result is discordant. -Complete and return the Field Correction Effectiveness Check Form attached to the letter within 30 days. -If you have received any complaints of illness or adverse events associated with the product listed in Table 1 of the letter, immediately contact your local Siemens Customer Care Center or their local Siemens Technical Support Representative

    Distribution

    Worldwide-domestic nationwide and foreign distribution.

    Quantity

    13435