# FDA recall Z-0205-2026

> **Diagnostica Stago, Inc.** · Class II · device recall initiated 2025-09-12.

## Product

Product: STA Liatest D-Di;  REF: 00515;

## Reason for recall

A potential risk of underestimation of D-Dimer (D-Di) levels with the two listed lots.

## Distribution

Worldwide distribution- US Nationwide and the country of Canada.

## Key facts

- **Recall number:** Z-0205-2026
- **Recalling firm:** Diagnostica Stago, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-09-12
- **Report date:** 2025-10-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Parsippany, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0205-2026

## Citation

> AI Analytics. FDA recall Z-0205-2026. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-0205-2026. Source: US FDA. Licensed CC0.

---

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