Recall Z-0500-2026— Accriva Diagnostics, Inc.

Name: FDA recall Z-0500-2026
Creator: U.S. Food and Drug Administration
Published: 2025-10-21

Class III · Ongoing

Class III FDA medical device recall by Accriva Diagnostics, Inc., initiated 2025-10-21. It names one FDA 510(k) clearance: K141427. Product: 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.. Reason: Due to an device without a premarket clearance being incorrectly package and distributed..

Recalling firm: Accriva Diagnostics, Inc.
Classification: Class III
Status: Ongoing
Initiated: 2025-10-21
Firm location: San Diego, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K141427 — ACCUMETRICS,INC. VERIFYNOW PRUTEST, ACCUMETRICS, INC. VERIFYNOW PRUTESTAccumetrics, Inc.·cleared 2015-07-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.