Access System - Total T4 Assay

Recall Summary The Access System - Total T4 Assay, a medical test used to measure thyroid hormone levels, is being recalled in Canada due to performance issues. This recall affects healthcare facilities and laboratories across Canada that use this assay system. The test may not perform as intended, which could impact the accuracy of thyroid function results.

Product
Access System - Total T4 Assay
Reason
Performance
Classification
Class I
Category
drug recall
Country
Canada
Agency
HC-DEVICES
Recall date
2024-02-15
Status
Ongoing
Distribution
Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/f9ab535c-8987-4ce2-93f0-f6bd85cea3d8