Architect "i" System - Stat Myoglobin Assay

Recall Summary Abbott Diagnostics is recalling the Architect "I" System - Stat Myoglobin Assay across Canada because the device was not authorized by Health Canada before being sold. This assay is used to measure myoglobin levels in blood samples to help diagnose heart attacks and other conditions. The recall affects all users of this product in Canada.

Product

Architect "I" System - Stat Myoglobin Assay

Reason

Unauthorised device

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2022-03-14

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/ef7c720a-08e4-4ceb-9d56-558350d1bf45