WhichRecall
Class IIReported 2025-12-10

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

Recalled by 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.

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Recall Number
Z-0880-2026
Classification
Class II
Status
Ongoing
Category
device
Initiated
2025-11-05
Reported
2025-12-10
Distribution
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.
Code Info
UDI-DI: 10711234103081. Lot: E5JLR132. Expiration: 08-31-2026
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
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