# FDA recall Z-0500-2026

> **Accriva Diagnostics, Inc.** · Class III · device recall initiated 2025-10-21.

## 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 for recall

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

## Distribution

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.

## Key facts

- **Recall number:** Z-0500-2026
- **Recalling firm:** Accriva Diagnostics, Inc.
- **Classification:** Class III
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-10-21
- **Report date:** 2025-11-19

- **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-0500-2026

## Citation

> AI Analytics. FDA recall Z-0500-2026. Retrieved 2026-08-18 from https://api.ai-analytics.org/recall/Z-0500-2026. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*