Sartorius recalls its VC3100 Virus Counter Platform due to potential safety risks in lab settings. Learn what to do if you own this device.
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.
Sartorius Corporation is recalling its Virus Counter Platform (model VC3100) because it's an automated lab instrument that could pose safety risks if misused. This device is used for virus quantification in biotech manufacturing but isn't a medical device.
The device is a Class 1 laser flow cytometer used for rapid virus quantification. While not a medical device, it involves high-risk components like lasers that could cause injury if the instrument malfunctions or is used improperly.
Lab researchers and biotech professionals who use the Virus Counter Platform for virus quantification in manufacturing processes are most at risk. The recall affects users of this specific model in laboratory settings.
Check for the model name VC3100 on the device or the product label. The specific model numbers VIR-92166 and VIR-92341 are also associated with this recall.
Look for the model name VC3100 or the model numbers VIR-92166, VIR-92341 on the device or label.
No, the Virus Counter is not a medical device but is used in biotech manufacturing for virus quantification.
The recall record does not specify a remedy, so no action is required beyond checking if you have the recalled model.
The recall record does not describe a specific hazard mechanism, so the risk level is unknown.
We’ve drafted a message you can send Sartorius to request your refund or repair — edit it as you like.
Subject: Recall Z-0946-2022 — Sartorius Sartorius Hello, I own a Sartorius that is covered by recall Z-0946-2022 from Sartorius. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
