Hemochron Activated Clotting Time Low-Range Test Cuvette recalled over foreign material

Recall date

November 5, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Accriva Diagnostics, Inc. recalls Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be used with the Hemochron Signature ELITE Wh…

Recall number

Z-0880-2026

FDA classification

Class II

Brand / firm

Accriva Diagnostics, Inc.

Sold / distributed

Worldwide - US Nationwide distribution including in the states of OH, IL, NY, GA, CA, IN, NJ, TX, KS, NE, FL, SC, MO, WV, WA, MI, CO, TN, PA, UT, LA, MT, NC, KY, TX and the countries of CA.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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