Recall Z-0880-2026— Accriva Diagnostics, Inc.

Name: FDA recall Z-0880-2026
Creator: U.S. Food and Drug Administration
Published: 2025-11-05

Class II · Ongoing

Class II FDA medical device recall by Accriva Diagnostics, Inc., initiated 2025-11-05. It names one FDA 510(k) clearance: K960749. 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: 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..

Recalling firm: Accriva Diagnostics, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-11-05
Firm location: San Diego, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K960749 — HEMOCHRON JR. MICROCOAGULATION LOW RANGE ACTInternational Technidyne Corp.·cleared 1996-08-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.