Rchitect System - Creatine Kinase Assay (2018-07-20)

Summary Roche Diagnostics is recalling the ARCHITECT System Creatine Kinase Assay used in hospitals and labs across Canada. The assay reagent may have reduced effectiveness, potentially leading to inaccurate test results for measuring creatine kinase levels in patient blood samples. This is a Class I recall, meaning there is a reasonable possibility that use of the product could cause serious adverse health consequences.

Reason

Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2018-08-02

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/0a04a185-5ef3-47e0-afcd-6838f19f6da9