Accriva Diagnostics
5 federal recalls on file, showing the 3 from the last 12 months. We monitor every CPSC, FDA, USDA, and NHTSA notice for Accriva Diagnostics and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-06-24FDA-DeviceClass IIAccriva directCHECK quality control recalled for incorrect labeling
Accriva Diagnostics' directCHECK ACT-LR whole blood quality control product (level 2, lot A6DLA001) has incorrect performance range information on its label. This labeling error could lead to misinterpretation of test results if the correct reference range is not known.
- 2025-12-10FDA-DeviceClass IIHemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be used with the Hemochron Signature ELITE Whole Blood Microcoagulation System
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.
- 2025-11-19FDA-DeviceClass IIIVerifyNow PRUTest Platelet Reactivity Test REF 85225 UDI-DI code: 10711234150078 The VerifyNow PRUTest is a whole blood test used in the laboratory or point of care setting to measure the level of platelet P2Y12 receptor blockade.
Due to an device without a premarket clearance being incorrectly package and distributed.
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