Health product recall

Vidas High Sensitive Troponin I (Tnhs)

Brand(s)
Last updated

Summary

Product
Vidas High Sensitive Troponin I (Tnhs)
Issue
Medical devices - Software defect
What to do

Contact the manufacturer if you require additional information.

Affected products

Affected Products

Lot or Serial Number

Model or catalog number

Vidas High Sensitive Troponin I (Tnhs)

All lots.

415386

Issue

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

Additional information

Details
Original published date: 2022-02-21
Alert / recall type
Health product recall
Category
Health product - Medical device - Chemistry
Companies

Biomerieux Sa

376, Chemin De L'Orme, Marcy-L'Etoile

France, 69280

Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-63938