# FDA recall Z-0946-2022

> **Sartorius Corporation** · Class II · device recall initiated 2022-03-11.

## Product

Virus Counter Platform with Model Name VC3100

## 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.

## Key facts

- **Recall number:** Z-0946-2022
- **Recalling firm:** Sartorius Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-03-11
- **Report date:** 2022-04-27

- **Voluntary/Mandated:** FDA Mandated
- **Location:** Arvada, CO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0946-2022

## Citation

> AI Analytics. FDA recall Z-0946-2022. Retrieved 2026-07-05 from https://api.ai-analytics.org/recall/Z-0946-2022. Source: US FDA. Licensed CC0.

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