Stratus Cs Acute Care System Cardiac Troponin-i Testpak (2019-06-04)

Recall Summary Stratus CS Acute Care System Cardiac troponin-i TestPak devices are being recalled across Canada due to a medical device issue classified as Class I, which indicates a serious problem. The TestPak is used to measure cardiac troponin-i levels, a marker of heart damage, in acute care settings. This recall affects healthcare facilities and providers using this device across Canada.

Reason

Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2019-06-21

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/84ac7575-8929-4a94-9129-ebfe12e57883