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accriva diagnostics, inc.

3 recalls on record

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Accriva Diagnostics, Inc. — directCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number: DCGLR-2

Assayed Whole blood control contains labeling with incorrect performance range.

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Accriva Diagnostics, Inc. — 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.

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Accriva Diagnostics, Inc. — 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 set

Due to an device without a premarket clearance being incorrectly package and distributed.