Accriva Diagnostics, Inc.: Device Recall

Recall Details

Recall Number

Z-0500-2026

Classification

Class III

Product Type

Device

Recalling Firm

Accriva Diagnostics, Inc.

Status

Ongoing

Date Initiated

10/21/2025

Location

San Diego, CA, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

125 boxes (3,125 tests)

Reason for Recall

Due to an device without a premarket clearance being incorrectly package and distributed.

Product Description

VerifyNow PRUTest Platelet Reactivity Test REF 85225 UDI-DI code: 10711234150078 The VerifyNow PRUTest is a whole blood test used in the laboratory or point of care setting to measure the level of platelet P2Y12 receptor blockade.

Distribution Pattern

Worldwide - U.S. Nationwide distribution in the states of AK, CA, FL, IA, IL, MD, MI, NY, SD, and TX. The countries of Hong Kong, Japan.

Other Recalls by Accriva Diagnostics, Inc.

• Class II: Risk 11/05/2025
  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.
• 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. →