Immulite System Anti-tg Ab And Immulite 1000 System - Thyroid Autoantibody Assay Anti-tg Ab (2018-04-25)

Recall Summary Siemens Healthcare Diagnostics is recalling Immulite System and Immulite 1000 System thyroid autoantibody tests (Anti-TG Ab assays) that were distributed across Canada. The tests may produce inaccurate results due to a manufacturing defect. This recall affects healthcare providers and laboratories that use these diagnostic devices to test for thyroid-related autoimmune conditions.

Reason

Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2018-05-11

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/d42c2c17-3de4-4ece-a521-5331b3cabfe1