Quantum Blue Adalimumab Assay

Recall Summary The Quantum Blue Adalimumab Assay, a diagnostic test used to measure adalimumab levels in patients, is being recalled across Canada because the test kits are failing prematurely and may not work as intended. This is classified as a serious safety issue (Class I recall). The product was distributed throughout Canada.

Product
Quantum Blue Adalimumab Assay
Reason
Premature failure
Classification
Class I
Category
drug recall
Country
Canada
Agency
HC-DEVICES
Recall date
2021-12-08
Status
Ongoing
Distribution
Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/ae6a1baf-9c86-4c93-81ac-0d9c89fabce1