# FDA recall Z-2764-2019

> **ELITech Group B.V.** · Class III · device recall initiated 2016-07-12.

## Product

Viva-ProE  Systems, Model # 6003-670, UDI: 03661540600357 - Product Usage: The ELITech Clinical Systems Selectra ProM is an automated clinical chemistry system intended for use in clinical laboratories. It is intended to be used for a variety of assay methods that have been applied to spectrophotometric and electrochemical techniques. The system has two core modules: one consisting of a spectrophoto-metric system for measurement of analytes using spectrophotometric techniques, such as end point, rate and turbidometric assays. The second module is an electro-meter used for measurement of electrolytes.

## Reason for recall

Software malfunction; The action  being taken due to the device becoming inoperable due to software lockup.

## Distribution

US Nationwide distribution including the state of NY.

## Key facts

- **Recall number:** Z-2764-2019
- **Recalling firm:** ELITech Group B.V.
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2016-07-12
- **Report date:** 2019-10-09
- **Termination date:** 2022-02-04

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2764-2019

## Citation

> AI Analytics. FDA recall Z-2764-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2764-2019. Source: US FDA. Licensed CC0.

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