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Sartorius Corporation recalls Virus Counter Platform with Model Name VC3100
Recalled April 27, 2022 · FDA recall Z-0946-2022 · Sartorius
Hazard
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. · FDA Class II
Units
82
Sold at
US Nationwide distribution.
Description
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.
Product
Virus Counter Platform with Model Name VC3100
Manufacturer(s)
Sartorius Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →