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Open, Classified

Virus Counter Platform with Model Name VC3100

FDA Recall Z-0946-2022 · Posted None

Recalling FirmSartorius Corporation
Recall StatusOpen, Classified
Product CodeREQ
Date Initiated2022-03-11
Product Quantity82

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.

Firm Action

Sartorius sent customer notification dated March 11, 2022 to all affected customers. Customers were informed that a field service personnel will be dispatch to update the labeling and provide an updated User Information manual (operator s manual) *. This work occurs at no cost to you regardless of scenario. You need only make the unit accessible for a few minutes for the representative to complete the upgrade.

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

US Nationwide distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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