Virus Counter Platform VC3100 Class II Medical Device Recall
Sartorius Corporation is recalling the Virus Counter Platform Model VC3100 (model numbers VIR-92166, VIR-92341) distributed nationwide to 82 units, classified as a Class II FDA medical device recall.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II FDA medical device recall. Although no illnesses or injuries have been reported, the FDA classification indicates a potential for harm that exceeds theoretical risk. The specific nature of the safety concern is not detailed in the provided source text.
Plain-English summary
Sartorius Corporation is recalling the Virus Counter Platform with Model Name VC3100 (model numbers VIR-92166 and VIR-92341). This instrument is an automated laboratory tool designed to rapidly quantify intact viruses in solution. It is used in process development and manufacturing of biotechnology products including vaccines, gene therapy, and personalized immunotherapy. The recall affects 82 units that were distributed nationwide.
The FDA has classified this as a Class II medical device recall of a Class 1 laser flow cytometer. This classification indicates a potential for harm to operators or users, though no illnesses or injuries related to the device have been reported.
Owners or operators of affected units should contact Sartorius Corporation for information regarding the recall and any necessary corrective actions.
The recalled product
- Product
- Virus Counter Platform with Model Name VC3100
- Manufacturer
- Sartorius Corporation
- Affected units
- 82
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Model Numbers VIR-92166
- VIR-92341
Distribution
Distributed nationwide across the United States.
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