Xpert® Bcr-abl Ultra

Xpert® BCR-ABL Ultra Recall Summary Xpert® BCR-ABL Ultra, a diagnostic test product, is being recalled across Canada due to performance issues. This product is used to measure BCR-ABL levels, which are relevant to certain blood cancer patients. The recall is classified as Class I, meaning there is a serious potential health risk.

Product

Xpert® BCR-ABL Ultra

Reason

Performance

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2025-11-19

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/e719ef04-f198-400a-bd35-29f5ae380142