# FDA recall Z-0038-2020

> **Vital Scientific N.V.** · Class II · device recall initiated 2018-09-07.

## Product

V-Twin, Catalog # 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

The action is being initiated because the cooling indicator board was improperly  installed. This was first noticed by a service employee during assembly. If for some reason the cooling of the reagent rotor fails, the reagent cooling indicator light will not illuminate and the acoustic beeper will not go off. As a consequence the operator will not be warned and the reagent storage conditions may fall out of specification.

## Distribution

US Nationwide distribution including the state of New York.

## Key facts

- **Recall number:** Z-0038-2020
- **Recalling firm:** Vital Scientific N.V.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-09-07
- **Report date:** 2019-10-16
- **Termination date:** 2022-06-29

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0038-2020

## Citation

> AI Analytics. FDA recall Z-0038-2020. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0038-2020. Source: US FDA. Licensed CC0.

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