Dvia Centaur System - Testosterone Assay (2016-04-05)

Recall Summary Roche Diagnostics is recalling the ADVIA Centaur System Testosterone Assay across Canada because the test can produce inaccurate results. This affects healthcare facilities and laboratories that use this automated testing system to measure testosterone levels in patient blood samples. The recall applies to all distributed units of this diagnostic assay.

Reason

Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2016-04-22

Status

Closed

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/374ba956-b6d2-4c92-9e8c-991e760e67c5