Virus Counter Platform with Model Name VC3100
Reported: April 27, 2022 Initiated: March 11, 2022 #Z-0946-2022
Product Description
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.
Details
- Recalling Firm
- Sartorius Corporation
- Units Affected
- 82
- Distribution
- US Nationwide distribution.
- Location
- Arvada, CO
Frequently Asked Questions
What product was recalled? ▼
Virus Counter Platform with Model Name VC3100. Recalled by Sartorius Corporation. Units affected: 82.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 27, 2022. Severity: Moderate. Recall number: Z-0946-2022.
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