Dimension Vista Lactate Dehydrogenase (LDI) Flex reagent cartridge, an in vitro diagnostic test for the quantitative measurement of lacta...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0499-2019.
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.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0499-2019.
Recall terminated by FDA.
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Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0499-2019.
Siemens Healthcare Diagnostics, Inc.
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Siemens Healthcare Diagnostics, Inc. Recall FAQ
Siemens Healthcare Diagnostics, Inc. is the subject of a diagnostic devices safety report: Dimension Vista Lactate Dehydrogenase (LDI) Flex reagent cartridge, an in vitro diagnostic test for the quantitative measurement of lacta.... The notice was published on October 11, 2018 by the U.S. Food and Drug Administration (FDA). Approximately 13,435 units are potentially affected.