FDAFDA · Food and drugs·Recall number Z-0946-2022
Virus Counter Platform with Model Name VC3100
Published April 27, 2022 · Recall initiated: March 11, 2022
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
FDA Mandated · Letter
Recall details
- Manufacturer
- Sartorius Corporation
- Distributor
- US Nationwide distribution.
- Lot
- Model Numbers VIR-92166, VIR-92341
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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