Dimension Exl System - Cardiac Troponin-I (CTnI) Assay

Siemens Healthcare Diagnostics Inc. has confirmed that Dimension Cardiac Troponin I (lTni and CTnI) lots (ea2314 and ga2323) shows a positive bias with lithium heparin plasma samples from individuals that are expected to be below the 99th percentile of 0.07 ng/ml. Troponin values as high as 0.20 ng/ml have been observed with lithium heparin plasma that are expected to be within the 99th percentile. Serum samples collected from normal, healthy individuals whose results fall within the reference interval or below the 99th percentile of 0.07 ng/ml were not impacted by this issue.

Recall start date: May 24, 2022