Viva-ProE Systems — Class III medical device recall Z-2764-2019
Terminated recall by ELITech Group B.V., reported 2019-10-09, distributed nationwide. Software malfunction; The action being taken due to the device becoming inoperable due to software lockup.
| Recall number | Z-2764-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ELITech Group B.V., Spankeren, N/A, Netherlands |
| Recall initiated | 2016-07-12 |
| Classified | 2019-09-30 |
| Reported by FDA | 2019-10-09 |
| Terminated | 2022-02-04 |
| Distributed | Nationwide (US) |
| Quantity | 89 units |
| Reason classes | device malfunction, software |
| UPC / GTIN / UDI-DI | 03661540600357 |
| Model numbers | 6003-670 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2764-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.