Immulite, Immulite 1000 System-turbo Intact Pth Assay (2019-03-17)

Summary Siemens Healthineers is recalling IMMULITE and IMMULITE 1000 System-Turbo Intact PTH assay kits used in Canada because the test results may be inaccurate due to a manufacturing issue. This affects healthcare facilities and laboratories that use this blood test to measure parathyroid hormone levels. The recall applies to all IMMULITE and IMMULITE 1000 systems across Canada that use this specific assay kit.

Reason

Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2019-04-05

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/3b40007d-c5a7-4a6e-91af-568e4d06908e