Spankeren, N/A, Netherlands
ELITech Group B.V. recalls
1 recall recorded since 2018, most recently on 12 July 2016. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class III Medical devices
- Recall started
- 12 July 2016
- Terminated
- 4 February 2022
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2764-2019
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.