Sartorius Corporation: Medical Device Recall in 2022 - (Recall #: Z-0946-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Virus Counter Platform with Model Name VC3100

Product Classification:

Class II

Date Initiated: March 11, 2022

Date Posted: April 27, 2022

Recall Number: Z-0946-2022

Event ID: 89818

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.

Status: Ongoing

Product Quantity: 82

Code Information:

Model Numbers VIR-92166, VIR-92341

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

FDA Mandated