Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be used with the Hemochron Signature ELITE Whole Blood Microcoagulation System

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    UDI-DI: 10711234103081. Lot: E5JLR132. Expiration: 08-31-2026
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Accriva Diagnostics, Inc.
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full 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 Codes/Lot Numbers:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0880-2026

Related Recalls

Class I - Dangerous

Platelet Reactivity Test distributed without appropriate US-FDA market clearance; if used healthcare personnel could use the baseline PRUTest measurement prior to initiating drug therapy, and then use the percent inhibition formula in the notice to manually calculate the percentage of platelet aggregation inhibition for a given patient receiving drug treatment with P2Y12 receptor inhibitor.

Dec 2, 2024 Diagnostic Equipment Nationwide View Details →