Sartorius Corporation recalls Virus Counter Platform with Model Name VC3100

Recall date

March 11, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0946-2022

FDA classification

Class II

Brand / firm

Sartorius Corporation

Sold / distributed

US Nationwide distribution.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Virus Counter Platform with Model Name VC3100