Z-0880-2026 Class II Ongoing
FDA device recall Z-0880-2026 was initiated by Accriva Diagnostics, Inc. on November 5, 2025 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 20250.
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