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Accriva Diagnostics, Inc. FDA Recalls
6 recalls on file across devices, 0 of them Class I and 4 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| directCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number: DCGLR-2Class IIApr 30, 2026Assayed Whole blood control contains labeling with incorrect |
| Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be used with the Hemochron Signature ELITE WhoClass IINov 5, 2025Test cuvettes, used with an assay for monitoring heparin ant |
| VerifyNow PRUTest Platelet Reactivity Test REF 85225 UDI-DI code: 10711234150078 The VerifyNow PRUTest is a whole blClass IIIOct 21, 2025Due to an device without a premarket clearance being incorre |
| VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064Class IIDec 2, 2024Platelet Reactivity Test distributed without appropriate US- |
| AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-operated bedside whole blood oximeter.Class IISep 27, 2024Values used to calibrate whole blood oximeter instruments we |
| The VerifyNow P2Y12 Test is designed to measure platelet P2Y12 receptor blockade. Substances known to specifically blockClass IIMar 30, 2022Two whole blood Platelet Reactivity tests exist that share t |