Siemens Dimension LTNI Cardiac Troponin Test Positive Bias Recall
Siemens is recalling the Dimension LTNI cardiac troponin-I test due to positive bias in Lithium Heparin plasma samples, which may cause false-positive results and inappropriate medical intervention.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The hazard poses a risk of diagnostic error and inappropriate medical intervention for myocardial infarction, fitting the criterion for risk-of-harm products without reported injury.
Plain-English summary
The Dimension LTNI is an in vitro diagnostic test used to measure cardiac troponin-I levels in blood samples to help diagnose myocardial infarction (heart attack). Siemens Healthcare Diagnostics is recalling 76 units of the test due to a positive bias affecting Lithium Heparin plasma samples.
The issue affects samples from individuals expected to have troponin-I levels below the 99th percentile threshold of 0.07 ng/mL (0.07 μg/L). The test demonstrates a positive bias on these samples, meaning it may report higher values than actually present, potentially leading to false-positive results and inappropriate medical intervention for myocardial infarction.
The affected product (Lot EA2314, expiration 11-10-2022) was distributed to 76 facilities across the United States and internationally. If you have received this product, contact Siemens Healthcare Diagnostics for guidance on replacement or disposal.
No illnesses or injuries have been reported in association with this recall.
The recalled product
- Product
- Dimension LTNI -In vitro diagnostic test intended to quantitively measure cardiac troponin-I levels in human serum and heparinized plasma to aid in the diagnosis of myocardial infarction. Siemens Material Number (SMN)/REF (Catalog Number): 10444896/RF521
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 76
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)
- UDI-DI: 00842768013904EA231420221110 Lot Number: EA2314 Exp. Date: 11-10-2022
Distribution
Part of a larger recall action
This product is one of 2 recalled by Siemens Healthcare Diagnostics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Siemens Healthcare Diagnostics, Inc.
See all →- HighSiemens Atellica CH C-Reactive Protein Reagent Recalled for Falsely Elevated Results
FDA (Devices) · 2026-10-07
- SevereSiemens Recalls Emit 2000 Quinidine Assay Due to Precision Issues
FDA (Devices) · 2026-08-26
- SevereSiemens Quinidine Assay Recalled for Precision Errors
FDA (Devices) · 2026-08-26
- HighSiemens Atellica CH Urine Albumin In Vitro Diagnostic Recall
FDA (Devices) · 2026-08-12
- LowSyva Emit Disopyramide Enzyme Immunoassay Calibrator Recalled for Sodium Azide Concentration
FDA (Devices) · 2026-08-12
Same hazard · test bias
See all →- HighAtellica CH Enzymatic Hemoglobin A1c assay well-to-well bias
FDA (Devices) · 2026-07-15
- ModerateSiemens SHBG Immulite 2000 Reagent Recall Due to Stability Issues
FDA (Devices) · 2017-06-07
Similar recalls
- ModerateSiemens Troponin I Reagent Cartridge Recalled for Positive Bias
FDA (Devices) · 2020-10-14
- HighSiemens Dimension Vista Troponin I Reagent Cartridge Recalled for Negative Bias
FDA (Devices) · 2020-09-09
- HighSiemens Stratus CS Acute Care cTNI TestPak Recalled for False Positives
FDA (Devices) · 2019-08-07
- HighSiemens Recalls Turbo Troponin I Diagnostic Kits for Potential Diagnostic Errors
FDA (Devices) · 2014-12-24
- ModerateSiemens Dimension LOCI Troponin I Calibrator Recalled for Result Shifts
FDA (Devices) · 2014-07-02
- HighStratus CS Acute Care cTNI TestPak cardiac troponin test recall
FDA (Devices) · 2025-05-07