Virus Counter Platform with Model Name VC3100

Company

Sartorius Corporation

Recall Initiated

March 11, 2022

Recall Number

Z-0946-2022

Quantity

82

Firm Location

Arvada, CO

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.

Lot / Code Info

Model Numbers VIR-92166, VIR-92341

Root Cause

Radiation Control for Health and Safety Act

Action Taken

Sartorius sent customer notification dated March 11, 2022 to all affected customers. Customers were informed that a field service personnel will be dispatch to update the labeling and provide an updated User Information manual (operator s manual) *. This work occurs at no cost to you regardless of scenario. You need only make the unit accessible for a few minutes for the representative to complete the upgrade.