FDA Medical Device Recalls (openFDA)
Sartorius Corporation: Virus Counter Platform with Model Name VC3100
- Recall number
- Z-0946-2022
- Recalling firm
- Sartorius Corporation
- Product
- Virus Counter Platform with Model Name VC3100
- Status
- Open, Classified
- Initiated
- 2022-03-11
- Posted
- not on file
- Terminated
- not on file
- Reason
- 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
- 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
- 82
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- Model Numbers VIR-92166, VIR-92341
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- REQ
- Firm FEI
- 3010058489
- Firm city
- Arvada
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28