Cardiac Troponin Diagnostic Test Recalled for Positive Bias in Plasma Samples
Siemens Dimension CTNI cardiac troponin test is recalled for positive bias (falsely elevated readings) in Lithium Heparin plasma samples, which may lead to misdiagnosis of myocardial infarction.
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 diagnostic device with risk of incorrect test results and potential clinical misinterpretation, but no reported patient illnesses or injuries. Risk-of-harm product where injury has not yet been reported.
Plain-English summary
The Siemens Dimension CTNI is an in vitro diagnostic test designed to measure cardiac troponin-I levels in blood to help diagnose myocardial infarction. The product is being recalled due to positive bias (falsely elevated test results) when testing Lithium Heparin plasma samples.
The positive bias specifically affects samples from individuals with cardiac troponin levels expected to be below the 99th percentile threshold of 0.07 ng/mL. These false elevations may lead to inappropriate clinical intervention and potential misdiagnosis of myocardial infarction.
Affected product includes lot GA2323 (expiring 11-19-2022) and lot BA3088 (expiring 03-29-2023). The recalled test kits were distributed worldwide, including throughout the United States and in Argentina, Brazil, Canada, France, Germany, India, Mexico, Poland, Portugal, and Slovakia.
The recalled product
- Product
- Dimension CTNI-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): 10444905/RF421C
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- false-positive-result
- diagnostic-error
Distribution
Distributed nationwide across the United States.
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