# FDA recall Z-0880-2026

> **Accriva Diagnostics, Inc.** · Class II · device recall initiated 2025-11-05.

## Product

Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be used with the Hemochron Signature ELITE Whole Blood Microcoagulation System

## Reason for recall

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.

## Distribution

Worldwide - US Nationwide distribution including in the states of OH, IL, NY, GA, CA, IN, NJ, TX, KS, NE, FL, SC, MO, WV, WA, MI, CO, TN, PA, UT, LA, MT, NC, KY, TX and the countries of CA.

## Key facts

- **Recall number:** Z-0880-2026
- **Recalling firm:** Accriva Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-11-05
- **Report date:** 2025-12-10

- **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-0880-2026

## Citation

> AI Analytics. FDA recall Z-0880-2026. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-0880-2026. Source: US FDA. Licensed CC0.

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