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.
What this means for you
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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