Vidas High Sensitive Troponin I (Tnhs)

Since January 2021, based on complaints received from the field related to critical non-repeatable overestimated results (changing interpretation according to the cutoff value, 19 ng/l, in the frame of the three hours algorithm that lead to a change in clinical interpretation) that lead to false positive results by some customers, Biomérieux initiated an investigation that is still ongoing.

It is important to keep in mind that it is commonly acknowledged among experts that both conventional and high sensitive troponin assays can lead to abnormally non-repeatable overestimated values especially in the lower part of the measuring range.

Recall start date: Jan 31, 2022