Summary
The FDA issued a Class II for Virus Counter Platform with Model Name VC3100 by Sartorius Corporation. Reason: The Virus Counter is an automated laboratory instrument that enables rapid quantification of intact viruses in solution. This instrument is not a medi.
Details
Source
Device Recall
External ID
Z-0946-2022
Action Date
2022-04-27
Status
Ongoing
Category
device
Product Description
Virus Counter Platform with Model Name VC3100
Lot/Code Info: Model Numbers VIR-92166, VIR-92341
Quantity Affected: 82
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.
Distribution
US Nationwide distribution.
Type: FDA Mandated
Recall Initiated: 2022-03-11
Company
Arvada, CO
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 150 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Sartorius Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Sartorius Corporation have FDA actions?
This is the only FDA action we have on record for Sartorius Corporation in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0946-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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