Unicel Immunoassay System, Ostate Assay, Calibrators And Qc (2016-10-25)

UNICEL Immunoassay System Recall Summary The UNICEL Immunoassay System's Ostate Assay calibrators and quality control materials are being recalled across Canada due to a device defect. This affects healthcare facilities and laboratories that use this system to perform Ostate tests. The recall is classified as Class I, meaning there is a serious potential health risk associated with the product.

Reason

Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2016-11-09

Status

Closed

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/9b3b54d8-14fd-450d-97cd-6d4f5229d98c