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Recall Observatory FDA recall evidence

Device product

Virus Counter Platform with Model Name VC3100

Z-0946-2022

March 11, 2022

Class II

Product summary

Firm
Sartorius Corporation
Event
Event 89818
Status
Ongoing
Classification
Class II
Quantity
82
Official record key
device-enforcement:Z-0946-2022

Official wording

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.

Code information: Model Numbers VIR-92166, VIR-92341

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.