Accriva Diagnostics, Inc.: Device Recall

Recall Details

Recall Number

Z-0880-2026

Classification

Class II

Product Type

Device

Recalling Firm

Accriva Diagnostics, Inc.

Status

Ongoing

Date Initiated

11/05/2025

Location

San Diego, CA, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

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.

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

Distribution Pattern

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.

Other Recalls by Accriva Diagnostics, Inc.

• Class III: Low Risk 10/21/2025
  Due to an device without a premarket clearance being incorrectly package and distributed.
• Class II: Risk 12/02/2024
  Platelet Reactivity Test distributed without appropriate US-FDA market clearance; if used healthcare personnel could use the baseline PRUTest measurement prior to initiating drug therapy, and then use the percent inhibition formula in the notice to manually calculate the percentage of platelet aggregation inhibition for a given patient receiving drug treatment with P2Y12 receptor inhibitor.
• Class II: Risk 09/27/2024
  Values used to calibrate whole blood oximeter instruments were observed to be higher than normal, which may result in incorrect patient results where oxygen levels are higher than actual results, which may lead to patient care mismanagement requiring medical intervention.

View all recalls by Accriva Diagnostics, Inc. →