# FDA recall Z-1585-2026

> **Diagnostica Stago, Inc.** · Class II · device recall initiated 2026-02-05.

## Product

Brand Name: STA Liatest D-Di  Product Name: STA Liatest D-Di  Model/Catalog Number: REF 00515  Product Description: The STA¿ - Liatest ¿ D-Di kit is an immuno-turbidimetric assay for the quantitative determination of D-dimer in venous plasma (in 3.2 % sodium citrate) for use on STA-R¿, STA Compact¿ and STA Satellite¿ analyzers by   professional laboratory personnel. The STA¿ - Liatest¿ D-Di is intended for use in conjunction with a clinical pretest probability (PTP) assessment model to exclude pulmonary embolism (PE) and deep venous thrombosis (DVT) in outpatients suspected of PE or DVT.  Component: No

## Reason for recall

After receiving customer complaints, investigations confirmed the presence of a positive bias in D-Dimer measurements throughout the entire analytical range.

## Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Singapore, Guam, Japan, South Korea, and Russia.

## Key facts

- **Recall number:** Z-1585-2026
- **Recalling firm:** Diagnostica Stago, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-02-05
- **Report date:** 2026-03-25

- **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-1585-2026

## Citation

> AI Analytics. FDA recall Z-1585-2026. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-1585-2026. Source: US FDA. Licensed CC0.

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