FDA Medical devices recall ·
Hemochron Activated Clotting Time Low-Range Test Cuvette recall
- Recall number
- Z-0880-2026
- Date
- (initiated November 5, 2025)
- Company / brand
- Accriva Diagnostics, Inc.
6260 Sequence Dr, San Diego, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 20250
- Hazard tags
- Foreign material Injury risk
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be used with the Hemochron Signature ELITE Whole Blood Microcoagulation System
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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.
States: California Colorado Florida Georgia Illinois Indiana Kansas Kentucky Louisiana Michigan Missouri Montana North Carolina Nebraska New Jersey New York Ohio Pennsylvania South Carolina Tennessee Texas Utah Washington West Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0880-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.