# FDA recall Z-0961-2025

> **Accriva Diagnostics, Inc.** · Class II · device recall initiated 2024-12-02.

## Product

VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064

## 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.

## Distribution

US Nationwide distribution in the state of VA.

## Key facts

- **Recall number:** Z-0961-2025
- **Recalling firm:** Accriva Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-12-02
- **Report date:** 2025-01-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Diego, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0961-2025

## Citation

> AI Analytics. FDA recall Z-0961-2025. Retrieved 2026-09-04 from https://api.ai-analytics.org/recall/Z-0961-2025. Source: US FDA. Licensed CC0.

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