Siemens Dimension Vista Lactate Dehydrogenase Reagent Cartridge Recall
Siemens is recalling Dimension Vista Lactate Dehydrogenase reagent cartridges because they may produce falsely elevated results if used after Lactic Acid assays.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the hazard is limited to potential diagnostic errors (falsely elevated results) rather than direct physical injury or death, fitting the Moderate criteria for low-risk contamination or labeling-like errors.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 13,435 units of Dimension Vista Lactate Dehydrogenase (LDI) Flex reagent cartridges. The affected product is an in vitro diagnostic test used to measure lactate dehydrogenase in human serum and plasma on the Dimension Vista System. The recall covers specific lot codes including 18240BA, 18199BA, 18162AC, 18155BB, 18106BC, 18073BE, 18036BC, and 17342BA.
The recall was initiated because the reagent cartridges may exhibit erroneously elevated results when the preceding assay in the reaction cuvette is Lactic Acid (LA). The cause is identified as incomplete removal of residual lactate dehydrogenase, a component of the LA reagent. This issue may impact both quality control and patient samples.
A falsely elevated result for lactate dehydrogenase may lead to additional investigations to determine the cause of tissue damage. Clinical laboratories should correlate results with patient history and other diagnostic testing. The affected units were distributed nationwide and internationally.
The recalled product
- 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
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 13,435
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 18240BA 18199BA 18162AC 18155BB 18106BC 18073BE 18036BC 17342BA
Distribution
Distributed nationwide across the United States.
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