Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2018 - (Recall #: Z-0499-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product 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

Product Classification:

Class II

Date Initiated: October 11, 2018

Date Posted: December 5, 2018

Recall Number: Z-0499-2019

Event ID: 81433

Reason for Recall:

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.

Status: Terminated

Product Quantity: 13435

Code Information:

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

Distribution Pattern:

Worldwide-domestic nationwide and foreign distribution.

Voluntary or Mandated:

Voluntary: Firm initiated