CLASS II Device recall · Reported 19 May 2021 · FDA Enforcement Report
Revogene Sars-CoV recalled by Meridian Bioscience
Meridian Bioscience is recalling Revogene Sars-CoV-2, distributed nationwide in the US. The recall was initiated on 8 Apr 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1540-2021
- FDA event ID
- 87556
- Recalling firm
- Meridian Bioscience, Cincinnati, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Apr 2021
- FDA classified
- 7 May 2021
- Reported
- 19 May 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 8 Apr 2021 | Recall initiated by company | |
| 7 May 2021 | Classified by FDA | +29 days |
| 19 May 2021 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Emergency Use Application (EUA) application withdrawn as false negative results reported
Product as listed by the FDA
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
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Emergency Use Application (EUA) application withdrawn as false negative results reported
Which lots are affected?
All lot numbers
Where was it sold?
Nationwide
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 87556| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Revogene RNA recalled by Meridian Bioscience | Meridian Bioscience | Potency & Assay | Nationwide |
More recalls from Meridian Bioscience
All 15| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Revogene C. difficile, in vitro diagnostic assay intended recalled | Meridian Bioscience | Potency & Assay | Nationwide |
| Device | CLASS II | Group B Streptococcus recalled by Meridian Bioscience | Meridian Bioscience | Foreign Material | 14 states |
| Device | CLASS II | alethia c. Difficile recalled by Meridian Bioscience | Meridian Bioscience | Foreign Material | 14 states |
| Device | CLASS II | Para-Pak Clean Vial-For the collection, transportation recalled | Meridian Bioscience | Foreign Material | Nationwide |
| Device | CLASS II | Para-Pak Zn-PVA/10% Formalin-for the routine collection recalled | Meridian Bioscience | Foreign Material | Nationwide |
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| Device | CLASS II | Systems/units containing affected recalled | Beckman Coulter Mishima K.K | Device Malfunction | Nationwide |
| Device | CLASS II | Fisher Scientific Sure-Vue Urine hCG recalled by Alere San Diego | Alere San Diego | Potency & Assay | Nationwide |