Meridian Bioscience recalls Revogene RNA Software Upgrade USBs (Catalog 610240) due to false negative results in emergency use applications. Affected units may not accurately detect certain conditions.
Emergency Use Application (EUA) application withdrawn as false negative results reported
Meridian Bioscience is recalling Revogene RNA Software Upgrade USBs (Catalog Number 610240) because they can cause false negative results in emergency use applications. This means the software might not correctly identify certain conditions, potentially leading to incorrect medical decisions.
The software upgrade USBs can produce false negative results when used in emergency applications. This means the system might incorrectly indicate that a condition is not present when it actually is, potentially leading to missed diagnoses. The issue occurs due to a withdrawal of the Emergency Use Authorization (EUA) by the manufacturer.
Healthcare professionals using the Revogene RNA Software Upgrade USBs for medical testing are likely affected. The risk is low as the issue relates to false negatives in emergency applications, not immediate harm.
Check if you have Revogene RNA Software Upgrade USBs with Catalog Number 610240. These were used to install the Revogene System Software version 4.2.0 for RNA-based assays.
Verify if your Revogene RNA Software Upgrade USBs have Catalog Number 610240.
The Emergency Use Application (EUA) for this software was withdrawn due to false negative results reported in medical testing.
Check if your Revogene RNA Software Upgrade USBs have Catalog Number 610240. If so, contact Meridian Bioscience for guidance.
The recall is for false negative results in emergency applications, not direct injury. The risk level is low.
We’ve drafted a message you can send Meridian Bioscience to request your refund or repair — edit it as you like.
Subject: Recall Z-1541-2021 — Meridian Bioscience Meridian Bioscience Hello, I own a Meridian Bioscience that is covered by recall Z-1541-2021 from Meridian Bioscience. 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.
