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FDANovember 5, 2025device

Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be used with the Hemochron Signature ELITE Whole Blood Microcoagulation System

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Ongoing

Brands named

accriva diagnosticsaccriva

UPCs

10711234103081

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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