Z-0946-2022 Class II Ongoing
FDA device recall Z-0946-2022 was initiated by Sartorius Corporation on March 11, 2022 and is designated Class II. 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 pr… The recall status is ongoing. Affected quantity: 82.
Recall Details
- Product Type
- Devices
- Report Date
- April 27, 2022
- Initiation Date
- March 11, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 82
Product Description
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.
Distribution Pattern
US Nationwide distribution.
Code Information
Model Numbers VIR-92166, VIR-92341