Virus Counter Platform with Model Name VC3100 — Class II medical device recall Z-0946-2022
Ongoing recall by Sartorius Corporation, reported 2022-04-27, distributed nationwide. The Virus Counter is an automated laboratory instrument that enables rapid quantification of intact viruses in
| Recall number | Z-0946-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | FDA mandated |
| Recalling firm | Sartorius Corporation, Arvada, CO, United States |
| Recall initiated | 2022-03-11 |
| Classified | 2022-04-15 |
| Reported by FDA | 2022-04-27 |
| Distributed | Nationwide (US) |
| Quantity | 82 |
| Model numbers | VIR-92166, VIR-92341 |
Product
Virus Counter Platform with Model Name VC3100
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0946-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.