Accriva Diagnostics, Inc.: Medical Device Recall in 2025 - (Recall #: Z-0961-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064

Product Classification:

Class II

Date Initiated: December 2, 2024

Date Posted: January 22, 2025

Recall Number: Z-0961-2025

Event ID: 96011

Reason for Recall:

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.

Status: Ongoing

Product Quantity: 25

Code Information:

UDI-DI: 10711234150054. Lot: WL1145. Expiration: 2025-10-18

Distribution Pattern:

US Nationwide distribution in the state of VA.

Voluntary or Mandated:

Voluntary: Firm initiated