CLASS II Device recall · Reported 19 May 2021 · FDA Enforcement Report
Revogene RNA recalled by Meridian Bioscience
Meridian Bioscience is recalling Revogene RNA, 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-1541-2021
- 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
- Potency & Assay
- 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Emergency Use Application (EUA) application withdrawn as false negative results reported
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
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Emergency Use Application (EUA) application withdrawn as false negative results reported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 87556This product is part of a recall event; the main page for the event is Revogene Sars-CoV recalled by Meridian Bioscience.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Revogene Sars-CoV recalled by Meridian Bioscience | Meridian Bioscience | Other | 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 | DxC 500 AU Clinical Chemistry Analyzers: AU w/out ISE recalled | Beckman Coulter | Device Malfunction | Nationwide |
| Device | CLASS II | DxC 500i Clinical Analyzer Modules: DxC 500 AU Module w/ISE recalled | Beckman Coulter | Device Malfunction | Nationwide |
| Device | CLASS II | McKesson Consult hCG Urine Cassette recalled by Alere San Diego | Alere San Diego | Potency & Assay | Nationwide |
| 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 |