FDAHealthNovember 5, 2025
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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- November 5, 2025
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.
What's affected?
- Product
- Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be used with the Hemochron Signature ELITE Whole Blood Microcoagulation System
- Lot code
- E5JLR132
Additional details
UDI-DI: 10711234103081. Lot: E5JLR132. Expiration: 08-31-2026
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 20250.
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