Siemens Troponin I Reagent Cartridge Recalled for Positive Bias
Siemens Healthcare Diagnostics is recalling Dimension LOCI High Sensitivity Troponin I reagent cartridges due to positive bias in test results.
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 source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling Dimension LOCI High Sensitivity Troponin I (TNIH) Flex reagent cartridges (Catalog Number: RF627, SMN# 10471068). The recall involves 533 units distributed in the US and 1,822 units distributed outside the US. The affected lot is EB0255.
The recall is due to a positive bias across the analytical measurement range of the assay compared to an unaffected control lot. The average bias observed for patient samples using lots EB0255 and EA0178 of the Dimension EXL Troponin compared with a control lot was +25%. A maximum bias of +34% in patient samples around the 99th percentile was observed.
This recall affects healthcare facilities and laboratories using the Dimension LOCI system for quantitative measurement of cardiac troponin I in human plasma. Users should stop using the affected lot and contact Siemens Healthcare Diagnostics for further instructions.
The recalled product
- Product
- Dimension LOCI High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-In vitro diagnostic use in the quantitative measurement of cardiac troponin I in human plasma Catalog Number: RF627, SMN# 10471068
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
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)
- Lot # EB0255 UDI: 00842768037726EB025520091110471068840
Distribution
Distributed nationwide across the United States.
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