Siemens Dimension LOCI Troponin I Calibrator Recalled for Result Shifts
Siemens is recalling Dimension LOCI Troponin I Calibrators because they may cause a 24% upward shift 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, and the hazard involves potential inaccuracy in diagnostic results without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 1,625 units of the Dimension LOCI TNI Troponin I Calibrator, lot number 3DD007. This in vitro diagnostic product is used to calibrate the cardiac troponin I method for the Dimension clinical EXL integrated chemistry system with LOCI module.
The recall was initiated because the calibrator may demonstrate an average upward shift of 24% in quality control and patient results following calibration. This shift could affect the accuracy of cardiac troponin I measurements.
The affected units were distributed nationwide in the United States, including Puerto Rico. Healthcare facilities should stop using the affected lot and contact Siemens for further instructions.
The recalled product
- Product
- Siemens Dimension LOCI TNI Troponin I Calibrator RC 621. The LOCI TNI Troponin I Calibrator is an in vitro diagnostic product for the calibration of the cardiac troponin I (TNI) method for the Dimension clinical EXL integrated chemistry system with LOCI module.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- Affected units
- 1,625
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 Number - 3DD007
Distribution
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