Accriva Diagnostics, Inc.: Medical Device Recall in 2025 - (Recall #: Z-0880-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: November 5, 2025

Date Posted: December 10, 2025

Recall Number: Z-0880-2026

Event ID: 97942

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.

Status: Ongoing

Product Quantity: 20250

Code Information:

UDI-DI: 10711234103081. Lot: E5JLR132. Expiration: 08-31-2026

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.

Voluntary or Mandated:

Voluntary: Firm initiated