Accriva Diagnostics, Inc.: Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be used with the Hemochron Signature ELITE Whole Blood Microcoagul
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- 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 / 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.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- 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.
- Recall initiated
- 2025-11-05
- Code info
- UDI-DI: 10711234103081. Lot: E5JLR132. Expiration: 08-31-2026
- Product quantity
- 20250
- Voluntary mandated
- Voluntary: Firm initiated
- City
- San Diego
- State
- CA
- Country
- United States
- Event id
- 97942
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