Meridian Bioscience recalls Revogene IVD test instrument (Catalog 610210) due to potential minor burns from heated components if run is aborted. Affected units have specific serial numbers.
When a run is aborted, the cooling period protection does not occur and the user is able to open the lid prior to the completion of the cooling period, exposing the user to heated instrument components. Incidental contact with heated instrument components may result in an injury such as minor burns.
Meridian Bioscience is recalling its Revogene IVD test instrument (Catalog no. 610210) because if a test run is stopped early, the instrument may heat up and cause minor burns. This risk occurs when users open the lid before the cooling period completes.
When a test run is aborted prematurely, the instrument fails to enter a cooling period. This allows heated components to remain exposed, which can cause minor burns if the user touches the instrument before it cools down.
Users of the Revogene IVD test instrument with the specific serial numbers listed in the recall are affected. Laboratory technicians and healthcare professionals who use this device are most at risk.
Check if your Revogene IVD test instrument has the catalog number 610210 and the listed serial numbers (many are provided in the recall notice). The device also has firmware version V2.1.0.
Verify if your Revogene IVD test instrument has the catalog number 610210 and the specific serial numbers listed in the recall.
If you abort a test run and open the lid before the cooling period completes, stop using the device immediately to avoid potential burns.
The recalled device is the Revogene IVD test instrument with catalog number 610210 and firmware version V2.1.0.
Check if your device has the catalog number 610210 and one of the specific serial numbers listed in the recall notice.
If you have the affected device, stop using it if you abort a test run and open the lid before the cooling period completes. Contact Meridian Bioscience for further instructions.
We’ve drafted a message you can send Meridian Bioscience to request your refund or repair — edit it as you like.
Subject: Recall Z-1479-2022 — Meridian Bioscience Meridian Bioscience Hello, I own a Meridian Bioscience that is covered by recall Z-1479-2022 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.
