Reported Dec 10, 2025 · Ongoing

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

Accriva Diagnostics, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Accriva Diagnostics, Inc. · 6260 Sequence Dr · San Diego, CA · 92121-4358

Is this the product you have?

  • Hemochron Activated Clotting Time Low-Range Test Cuvette
  • REFACT-LR, to be used with the Hemochron Signature ELITE Whole Blood Microcoagulation System
Lot codes and dates
  • UDI-DI10711234103081
  • LotE5JLR132
  • Expiration08-31-2026
Amount recalled
20250

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:12 PM UTC

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