Home / Brands / Accriva Diagnostics
Accriva Diagnostics Recalls
6 recalls on record · June 1, 2022 to June 24, 2026 · Medical Devices
Recalls by year
22
24
25
26
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
Also filed under
The recall feeds record what looks like the same company under more than one name:
June 24, 2026Medical DevicesFDA
Accriva Diagnostics, Inc. recalls directCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number: DCGLR-2
Hazard: Assayed Whole blood control contains labeling with incorrect performance range.
December 10, 2025Medical DevicesFDA
Accriva Diagnostics, Inc. recalls Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be used with the Hemochron Signature ELITE Who
Hazard: Test cuvettes, used with an assay for monitoring heparin anticoagulation, may have a foreign object that has sharp edges and could pose a risk of injury if not detected prior to handling.
November 19, 2025Medical DevicesFDA
Accriva Diagnostics, Inc. recalls VerifyNow PRUTest Platelet Reactivity Test REF 85225 UDI-DI code: 10711234150078 The VerifyNow PRUTest is a whole bl
Hazard: Due to an device without a premarket clearance being incorrectly package and distributed.
January 22, 2025Medical DevicesFDA
Accriva Diagnostics, Inc. recalls VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064
Hazard: 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.
November 6, 2024Medical DevicesFDA
Accriva Diagnostics, Inc. recalls AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-operated bedside whole blood oximeter.
Hazard: 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.
June 1, 2022Medical DevicesFDA
Accriva Diagnostics, Inc. recalls The VerifyNow P2Y12 Test is designed to measure platelet P2Y12 receptor blockade. Substances known to specifically block
Hazard: Two whole blood Platelet Reactivity tests exist that share the same reagent formulation and are used to obtain P2Y12 Reactivity Unit results. The test without US-FDA market clearance was distributed and it displays BASE results not displayed by the US-FDA market cleared device. A formula is being provided to health care personnel to calculate the percentage of platelet aggregation inhibition.