FDAClass IIApril 27, 2022

Virus Counter Platform with recall

Virus Counter Platform with Model Name VC3100

Why was Virus Counter Platform with 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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Model Numbers VIR-92166, VIR-92341

Product
Virus Counter Platform with Model Name VC3100
Recalling firm
Sartorius Corporation
Quantity
82
Distribution
US Nationwide distribution.
Recall date
April 27, 2022
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls