Sartorius Corporation 2022-04-27 Health serious FDA
Health · FDA · Recall #FDA-Z-0946-2022
Virus Counter Platform with Model Name VC3100 Recall
Issued April 27, 2022 · Sartorius Corporation
In April 2022, Sartorius Corporation recalled the Virus Counter Platform with Model Name VC3100, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using Virus Counter Platform with Model Name VC3100 right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Sartorius Corporation to arrange your fda mandated. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (FDA Mandated):
Recall details
- Brand
- Sartorius Corporation
- Category
- Health
- Recall date
- April 27, 2022
- Units affected
- Not reported
- Sold at
- US Nationwide distribution.
- Recall number
- FDA-Z-0946-2022
- Made in
- United States
- Issuing agency
- FDA
In context
- Sartorius Corporation has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 870th Health recall we've logged in 2022.