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

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.

Details from the source

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. Quantity: 20250 Lot/code info: UDI-DI: 10711234103081. Lot: E5JLR132. Expiration: 08-31-2026

UPC codes

10711234103081

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.