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.
What this means for you
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.
- Hazard
- test-bias
- false-positive
- diagnostic-error
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
Distributed nationwide across the United States.
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