Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be used with the Hemochron Signature ELITE Whole Blood Microcoagulation System
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.
From the FDA notice · Read the official notice ↗ · All Accriva Diagnostics recalls
What to do
The agency's notice has the remedy and who to contact.
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Compare your label or packaging with the recalled product.
- Product
- Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be used with the Hemochron Signature ELITE Whole Blood Microcoagulation System
- Sold in
- Nationwide
- Made for
- All ages (under 100 years)
Details
- Units affected
- 20250
- Illnesses reported
- None reported
- Manufactured in
- 6260 Sequence Dr, San Diego, CA, United States
- Classification
- Class II
- Recall number
- Z-0880-2026
In the FDA's words
- Description
- Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be used with the Hemochron Signature ELITE Whole Blood Microcoagulation System 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. UDI-DI: 10711234103081. Lot: E5JLR132. Expiration: 08-31-2026 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. Affected quantity: 20250
- Hazard
- 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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ModerateFDAOct 30, 2026