Dvia Centaur System- Ca19-9 Assay

Recall Summary Siemens Healthineers is recalling the ADVIA Centaur CA19-9 Assay (a medical test used to measure cancer marker levels) across Canada because the test results may be inaccurate due to a manufacturing defect. This affects healthcare facilities and laboratories that use this assay system to test patient samples. The recall is classified as Class I, meaning there is a serious potential for harm.

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2016-12-16

Status

Closed

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/e060842a-5de4-43d1-8fef-fbf1f785a63b