Virus Counter Platform (Sartorius) – Non-Medical Device (2022)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Virus Counter Platform with Model Name VC3100
Brand
Sartorius Corporation
Lot Codes / Batch Numbers
Model Numbers VIR-92166, VIR-92341
Products Sold
Model Numbers VIR-92166, VIR-92341
Sartorius Corporation is recalling Virus Counter Platform with Model Name VC3100 due to The Virus Counter is an automated laboratory instrument that enables rapid quantification of intact viruses in solution. This instrument is not a medi. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026