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Recall Observatory FDA recall evidence

Device product

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

Z-0880-2026

November 05, 2025

Class II

Product summary

Firm
Accriva Diagnostics, Inc.
Event
Event 97942
Status
Ongoing
Classification
Class II
Quantity
20250
Official record key
device-enforcement:Z-0880-2026

Official wording

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.

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.

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    foreign object

Field note

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