FDAClass IIMay 19, 2021

Revogene RNA Software Upgrade Kit Revogene RNA Software recall

Revogene RNA Software Upgrade Kit Revogene RNA Software Upgrade USBs Catalog Number: 610240 IVD used to install the Revogene System Software version…

Why was Revogene RNA Software Upgrade Kit Revogene RNA Software recalled?

Emergency Use Application (EUA) application withdrawn as false negative results reported

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All lot numbers

Product
Revogene RNA Software Upgrade Kit Revogene RNA Software Upgrade USBs Catalog Number: 610240 IVD used to install the Revogene System Software version…
Recalling firm
Meridian Bioscience Inc
Quantity
124 Revogene RNA Software Upgrade Kits
Distribution
Nationwide
Recall date
May 19, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls