Recall Z-0946-2022— Sartorius Corporation
Class II · Ongoing
Class II FDA medical device recall by Sartorius Corporation, initiated 2022-03-11. FDA's recall record names no specific 510(k) clearance for this event. Product: Virus Counter Platform with Model Name VC3100. Reason: 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..
- Recalling firm
- Sartorius Corporation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-03-11
- Firm location
- Arvada, CO, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.