Beckman Coulter Au Immunochemistry System- Hdl/ldl Cholesterol Assay

Recall Summary Beckman Coulter is recalling the AU Immunochemistry System HDL/LDL Cholesterol Assay across Canada due to performance issues with the test. This assay is a medical device used to measure cholesterol levels. The recall is classified as Class I, meaning there is a serious potential health risk associated with the product's performance.

Product

Beckman Coulter AU Immunochemistry System- HDL/LDL Cholesterol Assay

Reason

Performance

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2025-12-10

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/aaeb079f-1943-4ca2-bfe8-a29b50cf664b