Meridian Bioscience Revogene IVD Test Instrument Recall: Risk of Minor Burns
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.
Use caution until it’s fixed
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.
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/60469-meridian-bioscience-revogene-ivd-test-instrument-recall-risk-of-minor.
Source Summary by GovInfoNow · govinfonow.com/recall/60469-meridian-bioscience-revogene-ivd-test-instrument-recall-risk-of-minor · Updated August 10, 2026 · FDA enforcement record: FDA #Z-1479-2022
Cite this page
“Meridian Bioscience Revogene IVD Test Instrument Recall: Risk of Minor Burns.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/60469-meridian-bioscience-revogene-ivd-test-instrument-recall-risk-of-minor. Based on FDA recall #Z-1479-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1479-2022%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
Meridian Bioscience- Category
Medical device
What to do — step by step
Check Device Status
Verify if your Revogene IVD test instrument has the catalog number 610210 and the specific serial numbers listed in the recall.
Stop Using if Aborted
If you abort a test run and open the lid before the cooling period completes, stop using the device immediately to avoid potential burns.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide distribution - US Nationwide and the countries of Australia, Chile, Italy, Qatar, and Switzerland.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 42 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #Z-1479-2022 (June 22, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1479-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.