FDA recall: selected HemosIL HIT assay lots
Published November 4, 2026 · Coverage October 25–31, 2026, Pacific · High priority
FDA’s device-safety listing identifies an October 30 confirmed recall of selected lots of HemosIL AcuStar HIT-IgG(PF4-H), used with other information to aid assessment of heparin-induced thrombocytopenia. In the FDA page captured November 2, part 0009800127 is associated with lots B40005 and B38062, and part 0009802028 with lots B40006 and B38063. FDA describes a negative bias of 20–35% that may produce results below the 1.00 U/mL cutoff and be interpreted as HIT IgG antibody negative. The page also contains internally inconsistent error-type wording; its title and device-use description use different assay terminology.
Applicability and suggested action: FDA directs users to check the four listed lots, destroy remaining affected product under facility procedures, document the quantity and date on the Urgent Mandatory Response Tracking Form, and identify an alternative HIT antibody-testing method. FDA says decisions on prior results, follow-up or repeat testing belong to the laboratory and/or treating clinician under applicable procedures and clinical judgment. Confirm current FDA and manufacturer instructions; the November 2 capture does not establish the exact October 31 page version, and the manufacturer letter itself was not reviewed.
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