Recall Z-0499-2019— Siemens Healthcare Diagnostics, Inc.

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2018-10-11, terminated 2020-06-29. FDA's recall record names no specific 510(k) clearance for this event. Product: 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..

Recalling firm

Siemens Healthcare Diagnostics, Inc.

Classification

Class II

Status

Terminated

Initiated

2018-10-11

Terminated

2020-06-29

Firm location

Newark, DE, United States

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