Dimension Vista Cyclosporine System (csa) Assay (2019-07-02)

Recall Summary The Dimension Vista Cyclosporine System (CSA) Assay, a medical device used to measure cyclosporine levels in patient blood samples, is being recalled across Canada. The recall was issued due to issues with the device itself, classified as a serious safety concern. This affects healthcare facilities and laboratories in Canada that use this testing system.

Reason

Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2019-07-15

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/ae5c34e6-5812-4e0e-ab9a-6c64327fbfa8