Lower risk Medical device recall · FDA · Published February 15, 2022

Meridian Revogene: False positive results risk in lab testing

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.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0836-2022Medical device Meridian ›

Lower-risk recall

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.

Take action

Contact the company

Recalling firmMeridian Bioscience Inc3471 River Hills Dr · Cincinnati, OH 45244-3023

✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/61139-meridian-revogene-false-positive-results-risk-in-lab-testing.

Source Summary by GovInfoNow · govinfonow.com/recall/61139-meridian-revogene-false-positive-results-risk-in-lab-testing · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0836-2022

Cite this page

“Meridian Revogene: False positive results risk in lab testing.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61139-meridian-revogene-false-positive-results-risk-in-lab-testing. Based on FDA recall #Z-0836-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0836-2022%22&limit=1).

The FDA announced on Feb. 15, 2022, that Meridian Bioscience Inc is recalling Revogene nucleic acid testing instruments due to compromised photomultiplier tubes that may cause false-positive or indeterminate results. The agency classified the recall as Class II and ongoing.

How to tell if you have it

Brand: Meridian
Product: Revogene (For In Vitro Diagnostic use in performing nucleic acid testing in clinical laboratories)
Catalog Number 610210 (Meridian branded)
Catalog Number 130840 (GenePOC branded)
UDI: 00840733102318
All units in the field, all serial numbers

The hazard

According to the FDA, 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.

Context

GovInfoNow's records show Meridian Bioscience Inc has 8 other recalls on record since Dec. 17, 2018. Other recent recalls of similar products include the Revogene C. difficile Test Recall (Dec. 5, 2025), the Difficile Nucleic Acid Test Kit recall (Oct. 7, 2025), and the Para-Pak Clean Vial recall (Oct. 19, 2023). Other recent recalls of similar products include the Magellan LeadCare II Blood Lead Test Kits (March 13, 2026), S. Typhi/Para Ty false test results risk (Nov. 22, 2025), and the Magellan LeadCare Ultra Blood Lead Test Kit (March 13, 2026).

How to tell if you have this one

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.

Brand
Meridian
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Kit Details
Verify the catalog number and UDI to confirm if your Revogene kit is affected.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 40 states.

FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NV, NY, OH, OR, PA, PR, RI, SD, TN, TX, UT, VA, VT, WI, WV and the…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Alaska, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Jersey, New York, North Carolina, Ohio, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, West Virginia, Wisconsin.

Recall timeline

FDA published this recall 50 days after the firm started it.

Feb 15, 2022Firm started the recall
Mar 30, 2022FDA classified it Class II
Apr 6, 2022Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Do I need to stop using these kits immediately?

No, the recall does not require immediate stop use. The hazard is low risk and only affects test results, not safety.

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Link to this recall

<a href="https://govinfonow.com/recall/61139-meridian-revogene-false-positive-results-risk-in-lab-testing">Meridian Revogene: False positive results risk in lab testing (GovInfoNow)</a>

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-0836-2022 (February 15, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0836-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.