Arvada, CO, United States
Sartorius Corporation recalls
1 recall recorded since 2018, most recently on 11 March 2022. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 11 March 2022
- Reason
- The Virus Counter is an automated laboratory instrument that enables rapid quantification of intact viruses in solution. This instrument is not a medical device. The virus quantification is used in process development and manufacturing of various biotechnology products such as vaccines, gene therapy and personalized immunotherapy. Device is a Class 1 laser flow cytometer.
- Distribution
- US Nationwide distribution.
- Initiated
- FDA Mandated
- Recall number
- Z-0946-2022
- Virus Counter Platform with Model Name VC3100
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.