Z-0946-2022Class II

Virus Counter Platform with Model Name VC3100

Name: Z-0946-2022 Virus Counter Platform with Model Name VC3100
Creator: Sartorius Corporation
Published: 2022-03-11
License: https://open.fda.gov/license/

Sartorius, Inc. / initiated 2022-03-11 / Open, Classified / root cause: manufacturing process

FDA source

Sartorius Corporation began a recall of Virus Counter Platform with Model Name VC3100 on 2022-03-11. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0946-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-03-11
Posted: 2022-04-15
Recalling firm: Sartorius, Inc.
Product: Virus Counter Platform with Model Name VC3100
Product code: REQ Laser Rangefinders, Time-Of-Flight Speed Measurement Products
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.
Root cause tag: manufacturing process
FDA root cause: Radiation Control for Health and Safety Act
Action: Sartorius sent customer notification dated March 11, 2022 to all affected customers. Customers were informed that a field service personnel will be dispatch to update the labeling and provide an updated User Information manual (operator s manual) *. This work occurs at no cost to you regardless of scenario. You need only make the unit accessible for a few minutes for the representative to complete the upgrade.
Quantity in commerce: 82
Distribution: US Nationwide distribution.
Product codes and lots: Model Numbers VIR-92166, VIR-92341

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0946-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0946-2022	Class II	Ongoing	FDA Mandated	2022-04-27	2022-04-15

Product code REQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)