Tag: heparin_induced_thrombocytopenia

FDA Flags Most Serious Class of Recall for HemosIL AcuStar HIT-IgG (PF4-H) Test Kits

31 Oct 2026 9:30 a.m. · Source: US Food and Drug Administration

Instrumentation Laboratories (Werfen) has pulled four lots of its HemosIL AcuStar HIT-IgG (PF4-H) assay after confirming a negative bias that could mask heparin-induced thrombocytopenia.

Health Science & Technology Law Enforcement Medical Science Legal Business Product Recall HemosIL AcuStar HIT-IgG (PF4-H)Instrumentation Laboratories Werfen US Food and Drug Administration heparin-induced thrombocytopenia medical device Food Recalls FDA Drugs
Par Health Recalls 22 Lots of Argatroban Injection Nationwide Over Particulate Matter

14 Oct 2026 4:56 p.m.

The voluntary recall to the hospital/user level covers lots distributed nationwide between December 30, 2024, and May 5, 2026, after cellulose, polystyrene, polyethylene terephthalate, stopper material and possibly stainless steel were detected in certain lots.

Health Business Law Enforcement Medical Science Legal Social Issues Par Health Argatroban Injection Product Recall US Food and Drug Administration Particulate Matter Rochester, Michigan Pulmonary Emboli Food Recalls FDA Drugs Heparin-Induced Thrombocytopenia MedWatch