Accriva Diagnostics, Inc.
2 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Accriva Diagnostics, Inc. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-01-22FDA-DeviceClass IIVerifyNow P2Y12 Platelet Reactivity Test, REF: 85064
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.
- 2024-11-06FDA-DeviceClass IIAVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-operated bedside whole blood oximeter.
Values used to calibrate whole blood oximeter instruments were observed to be higher than normal, which may result in incorrect patient results where oxygen levels are higher than actual results, which may lead to patient care mismanagement requiring medical intervention.
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