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Home › FDA recalls › Hemochron Activated Clotting Time Low-Range Test Cuvette
CLASS II · ModerateFDA

Accriva Diagnostics, Inc. recalls Hemochron Activated Clotting Time Low-Range Test Cuvette

📅 Nov 5, 2025 · 📍 Nationwide
Recalling company
Accriva Diagnostics, Inc.
Product
Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be used with the Hemochron Signature ELITE Whole Blood Microcoagulation System
Reason
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.
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Nov 5, 2025
Reported
Dec 10, 2025
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.
Status
Ongoing
Quantity
20250
Lot / codes
UDI-DI: 10711234103081. Lot: E5JLR132. Expiration: 08-31-2026
Company location
San Diego, CA
Recall type
Voluntary: Firm initiated
Recall number
Z-0880-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-0880-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.