Sartorius Corporation Recall 89818
Description: Virus Counter Platform with Model Name VC3100
Sartorius Corporation Recall 89818 Information
| Status | Ongoing |
| Mandated? | FDA Mandated |
| Recall Number | Z-0946-2022 |
| Event ID | 89818 |
| Event Description | Virus Counter Platform with Model Name VC3100 |
| Product Type | Devices |
| Distribution | US Nationwide distribution. |
| Quantity | 82 |
| Recall 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. |
| Device Classification | 20220427 |
| Device Code Info | Model Numbers VIR-92166, VIR-92341 |
| Center Classification Date | 20220415 |
| Recall Initiation Date | 20220311 |
| Recalling Firm | Sartorius Corporation |
| Initial Notification | Letter |
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