Hemochron Test Cuvettes Recalled for Potential Sharp Foreign Objects

Agency Publication Date: December 3, 2025

Summary

Accriva Diagnostics, Inc. is recalling 20,250 Hemochron Activated Clotting Time Low-Range Test Cuvettes (Model ACT-LR). These test cuvettes, which are used with the Hemochron Signature ELITE system to monitor heparin levels, may contain a foreign object with sharp edges. If you have these cuvettes in your laboratory or clinical setting, stop using them immediately and contact the manufacturer or your distributor to arrange for a return or replacement.

Risk

The cuvettes may contain a sharp foreign object that could cause cuts or other injuries to healthcare workers or laboratory staff during handling if the defect is not noticed.

What You Should Do

This recall affects Hemochron Activated Clotting Time Low-Range Test Cuvettes (REF: ACT-LR) with Lot number E5JLR132 and an expiration date of 08-31-2026.
Identify the affected product by checking for UDI-DI 10711234103081 on the packaging or the cuvette itself.
Stop using the recalled test cuvettes immediately to avoid the risk of injury from sharp edges.
Contact Accriva Diagnostics, Inc. or your authorized distributor to arrange for the return, replacement, or correction of the affected test cuvettes.
Call the FDA Consumer Complaint hotline at 1-888-463-6332 for additional questions regarding this medical device recall.

Your Remedy Options

Other Action

Manufacturer correction or return

How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Hemochron Activated Clotting Time Low-Range Test Cuvette

Model / REF:

ACT-LR

Lot Numbers:

E5JLR132 (Exp 08-31-2026)

UDI:

10711234103081

Used with the Hemochron Signature ELITE Whole Blood Microcoagulation System.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 97942

Status: Active

Manufacturer: Accriva Diagnostics, Inc.

Sold By: Medical distributors; Direct laboratory sales

Manufactured In: United States

Units Affected: 20250

Distributed To: Ohio, Illinois, New York, Georgia, California, Indiana, New Jersey, Texas, Kansas, Nebraska, Florida, South Carolina, Missouri, West Virginia, Washington, Michigan, Colorado, Tennessee, Pennsylvania, Utah, Louisiana, Montana, North Carolina, Kentucky

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects Hemochron Activated Clotting Time Low-Range Test Cuvettes (REF: ACT-LR) with Lot number E5JLR132 and an expiration date of 08-31-2026.

Identify the affected product by checking for UDI-DI 10711234103081 on the packaging or the cuvette itself.

Stop using the recalled test cuvettes immediately to avoid the risk of injury from sharp edges.

Contact Accriva Diagnostics, Inc. or your authorized distributor to arrange for the return, replacement, or correction of the affected test cuvettes.

Call the FDA Consumer Complaint hotline at 1-888-463-6332 for additional questions regarding this medical device recall.