FDA recall Z-0946-2022

Sartorius Corporation · Class II · device

Product

Virus Counter Platform with Model Name VC3100

Reason for recall

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.

Key facts

Status
Ongoing
Initiation date
2022-03-11
Report date
2022-04-27
Voluntary/Mandated
FDA Mandated
Location
Arvada, CO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0946-2022