Meridian Bioscience recalls Revogene lab test kits due to potential false positives in nucleic acid testing. Affected units include all field models with specific catalog numbers.
The photomultiplier tube, may have compromised functionality in some instruments. As a result, the user is likely to observe an increase in false-positive or indeterminate results.
Meridian Bioscience is recalling Revogene lab test kits because their photomultiplier tubes might cause false positive or indeterminate results in nucle:ic acid testing. This could lead to incorrect lab diagnoses if not fixed.
The photomultiplier tube in some Revogene kits may not function properly, causing the lab equipment to show false positive or indeterminate results. This means tests might incorrectly indicate a condition is present when it isn't.
Clinical laboratory users who perform nucleic acid testing with Revogene kits are affected. Lab technicians and medical staff using these kits are most at risk of incorrect test results.
Check for Revogene kits with catalog numbers 610210 (Meridian branded) or 130840 (GenePOC branded) with UDI 00840733102318. All units in the field are affected, regardless of serial number.
Verify the catalog number and UDI to confirm if your Revogene kit is affected.
No, the recall does not require immediate stop use. The hazard is low risk and only affects test results, not safety.
Check the catalog number and UDI to confirm if your kit is affected. If so, contact Meridian Bioscience for guidance.
No safety risks are mentioned; the hazard is limited to potential false positive results in lab testing.
We’ve drafted a message you can send Meridian to request your refund or repair — edit it as you like.
Subject: Recall Z-0836-2022 — Meridian Meridian Hello, I own a Meridian that is covered by recall Z-0836-2022 from Meridian. 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.
