Accriva Diagnostics recalls
6 federal recalls on file, showing the 4 from the last 12 months. We read every CPSC, FDA, USDA and NHTSA notice for Accriva Diagnostics and put it in plain English.
Recent recalls
Accriva Hemochron Jr. APTT cuvettes recalled for inaccurate resultsAccriva Diagnostics is recalling certain Hemochron Jr. APTT test cuvettes, used to check low-dose heparin levels in blood. The clot-activating reagent inside some cuvettes may be out of position or missing, which can cause error codes or falsely high results. Falsely high results could lead to a lower anticoagulant dose than needed, which could raise the risk of blood clots. No injuries have been reported.
ModerateFDAOct 30, 2026
- Accriva 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.
ModerateFDAJun 24, 2026
- Hemochron 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.
FDADec 10, 2025
- VerifyNow 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.
FDANov 19, 2025