Meridian Bioscience recalls Revogene SARS-CoV-2 test (Catalog 410700) due to reported false negative results in emergency use. All units affected.
Emergency Use Application (EUA) application withdrawn as false negative results reported
Meridian Bioscience is recalling its Revogene SARS-CoV-2 test (Catalog Number 410700) because it has reported false negative results. This means the test might not correctly detect COVID-19, potentially leading to incorrect negative results.
The test has reported false negative results, meaning it may fail to detect SARS-CoV-2 in some cases. This could lead to incorrect negative results when the person is actually infected with COVID-19.
Individuals who purchased or use the Revogene SARS-CoV-2 test (Catalog 410700) for COVID-19 testing are affected. Those who rely on this test for accurate results may be at risk of false negatives.
Check for the product name 'Revogene SARS-CoV-2' and catalog number 410700. All units are affected, so no specific lot numbers or dates are required.
Verify the product name and catalog number to confirm if it matches the recalled item.
The recall is due to reported false negative results in emergency use, meaning the test might not correctly detect SARS-CoV-2 in some cases.
No, all units of the Revogene SARS-CoV-2 test (Catalog Number 410700) are affected.
Check the product details to confirm if it matches the recalled item. No specific action is required beyond verification.
We’ve drafted a message you can send Meridian Bioscience to request your refund or repair — edit it as you like.
Subject: Recall Z-1540-2021 — Meridian Bioscience Meridian Bioscience Hello, I own a Meridian Bioscience that is covered by recall Z-1540-2021 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.
