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Sartorius Corporation Recall 89818

Description: Virus Counter Platform with Model Name VC3100

Sartorius Corporation Recall 89818 Information

Mandated?FDA Mandated
Recall NumberZ-0946-2022
Event ID89818
Event DescriptionVirus Counter Platform with Model Name VC3100
Product TypeDevices
DistributionUS Nationwide distribution.
Recall ReasonThe 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 Classification20220427
Device Code InfoModel Numbers VIR-92166, VIR-92341
Center Classification Date20220415
Recall Initiation Date20220311
Recalling FirmSartorius Corporation
Initial Notification Letter
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