Ccess System & Unicel Dxi 600/800 Access Immunoassay System - Unconjugated Estriol Assay (2020-08-31)

Recall Summary Unicel DXI 600/800 Access Immunoassay Systems with the Unconjugated Estriol Assay are being recalled across Canada due to a medical device issue. The recall is classified as Class I, indicating a serious problem with the device. 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

2020-09-18

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/d93c459f-872b-4c40-a650-800303d50e57