“Meridian Bioscience Revogene SARS-CoV-2 Test Recall: False Negative Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62815-meridian-bioscience-revogene-sars-cov-2-test-recall-false-negative. Based on FDA recall #Z-1540-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1540-2021%22&limit=1).
The FDA announced on April 8, 2021, that Meridian Bioscience Inc voluntarily recalled the Revogene SARS-CoV-2 Catalog Number 410700 IVD test kit. The recall follows the withdrawal of the Emergency Use Application due to reported false negative results.
The recall was initiated because the Emergency Use Application for the device was withdrawn after false negative results were reported. The product is a qualitative test for detecting SARS-CoV-2 nucleic acid from nasopharyngeal swab specimens.
Context
GovInfoNow's records show Meridian Bioscience Inc has had 8 other recalls on record since December 17, 2018. Other recent recalls of similar products include the BioFire Spotfire Respiratory Panel Recall (April 1, 2026), the Siemens Healthineers Immulite 2000 Syphilis Screen Recall (July 13, 2026), and the BioFire Respiratory Panel 2.1 Recall (October 22, 2025).
How to tell if you have this one
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.
Brand
Meridian Bioscience
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
Nationwide
Recall number
Product, codes & lots
Quantity
Z-1540-2021
Revogene SARS-CoV-2 Catalog Number: 410700 IVD for real-time Reverse Transcription Polymerase Chain Reaction (rRT-PCR) qualitative test run on the Revogene¿ instrument for the detection of SARS-CoV-2 nucleic acid from nasopharyngeal swab (NPS) specimens from individuals suspected of COVID-19; All lot numbers
376 kits of the Revogene SARS-CoV-2 assay
Z-1541-2021
Revogene RNA Software Upgrade Kit Revogene RNA Software Upgrade USBs Catalog Number: 610240 IVD used to install the Revogene System Software version 4.2.0, import the Revogene Instrument Control Protocol file for RNA-based assay, and install the Assay Definition File (ADF) file; All lot numbers
124 Revogene RNA Software Upgrade Kits
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the product name and catalog number to confirm if it matches the recalled item.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 7 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-1540-2021 (April 8, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1540-2021 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.