Z-0880-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- December 10, 2025
- Initiation Date
- November 5, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20250
Product Description
Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be used with the Hemochron Signature ELITE Whole Blood Microcoagulation System
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 Pattern
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.
Code Information
UDI-DI: 10711234103081. Lot: E5JLR132. Expiration: 08-31-2026