FDA Device recall Z-0946-2022
Virus Counter Platform with Model Name VC3100
- FDA Device
- Class II
- ongoing
- Published 2022-04-27
On 2022-04-27 the FDA classified a Class II recall of Virus Counter Platform with Model Name VC3100 by Sartorius, citing 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 quantif….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0946-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-03-11 |
| Published | 2022-04-27 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Sartorius |
| Distribution | US |
Product
Virus Counter Platform with Model Name VC3100
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.
Identifiers
| code_info | Model Numbers VIR-92166, VIR-92341 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0946-2022%22
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