Tag: instrumentation_laboratories

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