Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be used with the Hemochron Signature ELITE Who
Summary
The FDA issued a Class II for Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be use by Accriva Diagnostics, Inc.. 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 inju.
Details
Source
Device Recall
External ID
Z-0880-2026
Action Date
2025-12-10
Status
Ongoing
Category
device
Product Description
Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be used with the Hemochron Signature ELITE Whole Blood Microcoagulation System
Lot/Code Info: UDI-DI: 10711234103081. Lot: E5JLR132. Expiration: 08-31-2026
Quantity Affected: 20250
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.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-11-05
Company
San Diego, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 336 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Accriva Diagnostics, Inc. has 8 FDA actions in our database, including 6 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Accriva Diagnostics, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Accriva Diagnostics, Inc. have FDA actions?
Accriva Diagnostics, Inc. has 8 FDA actions in our database, including 6 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0880-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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