Platelet Reactivity Test distributed without appropriate US-FDA market clearance; if used healthcare personnel could use the baseline PRUTest measurement prior to initiating drug therapy, and then use the percent inhibition formula in the notice to manually calculate the percentage of platelet aggregation inhibition for a given patient receiving drug treatment with P2Y12 receptor inhibitor.
Reason for recall: Platelet Reactivity Test distributed without appropriate US-FDA market clearance; if used healthcare personnel could use the baseline PRUTest measurement prior to initiating drug therapy, and then use the percent inhibition formula in the notice to manually calculate the percentage of platelet aggregation inhibition for a given patient receiving drug treatment with P2Y12 receptor inhibitor. Distribution: US Nationwide distribution in the state of VA. Quantity: 25 Lot/code info: UDI-DI: 10711234150054. Lot: WL1145. Expiration: 2025-10-18
10711234150054
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.