Home / Recalls / Siemens Healthcare Diagnostics, Inc. / Z-0499-2019

Z-0499-2019 Class II Terminated

Recalled by Siemens Healthcare Diagnostics, Inc. — Newark, DE

FDA device recall Z-0499-2019 was initiated by Siemens Healthcare Diagnostics, Inc. on Oct 11, 2018 and is designated Class II. 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… The recall status is terminated (terminated Jun 29, 2020). Affected quantity: 13435.

Recall Details

Product Type
Devices
Report Date
Dec 5, 2018
Initiation Date
Oct 11, 2018
Termination Date
Jun 29, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
13435

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

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.

Distribution Pattern

Worldwide-domestic nationwide and foreign distribution.

Code Information

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

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-0499-2019
openFDA file date
Oct 23, 2026
Loaded by RegDataLab
Oct 24, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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FDA data resources