Medical Device Recall: Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be used with the Hemochron Signature ELITE Whole Blood Microcoagulation System
Accriva Diagnostics, Inc. · November 5, 2025
Reason for Recall
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.
Distribution
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.
States Affected
NATIONWIDE
Quantity Affected
20250
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0880-2026
Status: ongoing
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