Rchitect I System - Dhea-s Assay (2017-12-19)

Recall Summary The ARCHITECT I System - DHEA-S Assay, a medical device used to measure DHEA-S hormone levels, is being recalled across Canada. The recall is classified as Class I, meaning there is a serious potential health risk. The device was distributed throughout Canada.

Reason

Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2018-01-08

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/b4f80381-d2d2-4d1b-83ec-521acaaf1ccb