# FDA recall Z-2558-2019

> **Vital Scientific N.V.** · Class II · device recall initiated 2016-01-18.

## Product

V-Twin, Model # 6002-800, UDI: 03661540600180    Product Usage:  An in-vitro diagnostic device, which is an automated chemistry analyzer, micro type, intended for clinical use in conjunction with certain materials to measure a variety of analytes, including applications in clinical chemistry, monitoring drugs of abuse and in therapeutic drug monitoring.

## Reason for recall

Instrument stopped working due to a software lockup, and no patient results are produced.

## Distribution

US in the state of New York.

## Key facts

- **Recall number:** Z-2558-2019
- **Recalling firm:** Vital Scientific N.V.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2016-01-18
- **Report date:** 2019-10-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Dieren, Netherlands

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2558-2019

## Citation

> AI Analytics. FDA recall Z-2558-2019. Retrieved 2026-07-18 from https://api.ai-analytics.org/recall/Z-2558-2019. Source: US FDA. Licensed CC0.

---

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