FDA Enforcement
Class II
Ongoing
Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be used with the Hemochron Signature ELITE Whole Blood Microcoagulation System
Recall: Z-0880-2026
·
Reported December 10, 2025
Enforcement
- Recall Number
- Z-0880-2026
- Event ID
- 97942
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Accriva Diagnostics, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Report Date
- December 10, 2025
- Initiation Date
- November 5, 2025
- Classification Date
- December 3, 2025
- Address
- 6260 Sequence Dr, San Diego, CA, 92121-4358, United States
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
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.
Code Info
UDI-DI: 10711234103081. Lot: E5JLR132. Expiration: 08-31-2026
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.
Quantity
20250