Z-0499-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 5, 2018
- Initiation Date
- October 11, 2018
- Termination Date
- June 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