Dimension Exl System - Cardiac Troponin-i (ctni) Assay

Recall Summary Siemens Healthineers is recalling the Dimension Exl System - Cardiac Troponin-I (CTnI) Assay across Canada due to performance issues with the test. This assay is used in hospitals and laboratories to measure cardiac troponin levels in blood samples to help diagnose heart conditions. The recall affects all Canadian healthcare facilities that use this cardiac testing system.

Product

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

Reason

Performance

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2022-06-13

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/6e905796-6d89-40cf-bdd7-747ec5c04ec1