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Software defect concerning autosave mechanism may result in the clinician administering incorrect medication(s).
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.
A possible sterility issue was detected in Coloplast's facility on some Coloplast products.