Hemosil Acustar Hit-igg(pf4-h)

Recall Summary Instrumentation Laboratory Co. is recalling the HemosIL AcuStar HIT-IgG(PF4-H) diagnostic device across Canada due to a device performance issue. This device is used to test for heparin-induced thrombocytopenia (HIT), a blood clotting condition that can develop in patients receiving certain blood thinners. The recall is classified as Class II, meaning the device may not perform correctly but poses limited risk of serious harm.

Product

HemosIL AcuStar HIT-IgG(PF4-H)

Reason

Device performance issue

Classification

Class II

Category

medical device recall

Country

Canada

Agency

HC-DEVICES

Recall date

2026-10-15

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/b0c4f501-ec77-4141-bb4d-7e77e9950f36