Ccess System - Cortisol Assay, Unicel Dxi 600 And 800 Access Immunoassay System - Cortisol Assay (2018-09-16)

Beckman Coulter is recalling the Access System Cortisol Assay test kits used with UniCel DxI 600 and 800 immunoassay systems across Canada. The recall was issued because the test kits are classified as medical devices with a potential safety or effectiveness issue. This recall affects healthcare facilities and laboratories that use these cortisol testing systems.

Reason
Medical devices
Classification
Class I
Category
drug recall
Country
Canada
Agency
HC-DEVICES
Recall date
2018-10-19
Status
Ongoing
Distribution
Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/d8fae889-efa0-452c-bdbb-286dd5bfe670