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U.S. Department of Health and Human Services

Class 2 Device Recall Sartorius or Virocyt

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 Class 2 Device Recall Sartorius or Virocytsee related information
Date Initiated by FirmMarch 11, 2022
Create DateApril 15, 2022
Recall Status1 Open3, Classified
Recall NumberZ-0946-2022
Recall Event ID 89818
Product Classification Laser Rangefinders, Time-of-Flight Speed Measurement Products - Product Code REQ
ProductVirus Counter Platform with Model Name VC3100
Code Information Model Numbers VIR-92166, VIR-92341
Recalling Firm/
Manufacturer		 Sartorius Corporation
6542 Fig St
Arvada CO 80004-1042
For Additional Information ContactTerri Brooks
631-469-9877
Manufacturer 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.
FDA Determined
Cause 2		Radiation Control for Health and Safety Act
ActionSartorius 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.
Quantity in Commerce82
DistributionUS Nationwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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