CLASS II ONGOING Device recall · Reported 1 Feb 2023 · FDA Enforcement Report
Revogene Sars-CoV-2_IVD real-time Rt-pcr test intended recalled
Meridian Bioscience is recalling Revogene Sars-CoV-2_IVD real-time Rt-pcr test intended for the qualitative detection of, distributed nationwide in the US. The recall was initiated on 15 Dec 2022 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-1008-2023
- FDA event ID
- 91356
- Recalling firm
- Meridian Bioscience, Cincinnati, OH
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 15 Dec 2022
- FDA classified
- 20 Jan 2023
- Reported
- 1 Feb 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Foreign Material
- Device type
- Test Kits & Diagnostics
Timeline
| 15 Dec 2022 | Recall initiated by company | |
| 20 Jan 2023 | Classified by FDA | +36 days |
| 1 Feb 2023 | 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
Leakage of the original specimen from the plastic microfluidic cartridge (PIE), possibility that laboratory personnel may be exposed to aerosolized specimen containing SARS-CoV-2
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Revogene SARS-CoV-2_IVD real-time RT-PCR test intended for the qualitative detection of RNA from SARSCoV-2 Catalog Number: 410700
Where it was distributed
US Nationwide distribution in the states of AZ, CA, IN, KS, KY, LA, MI, MN, NC, NY, OR, TX.
Nationwide ArizonaCaliforniaIndianaKansasKentuckyLouisianaMichiganMinnesotaNorth CarolinaNew YorkOregonTexas
Questions about this recall
Why was it recalled?
Leakage of the original specimen from the plastic microfluidic cartridge (PIE), possibility that laboratory personnel may be exposed to aerosolized specimen containing SARS-CoV-2
Which lots are affected?
UDI: N/A Lot Numbers 410700P019, 410700P020, 410700P021, 410700P022, 410700P023, 410700P024, 410700P027
Where was it sold?
US Nationwide distribution in the states of AZ, CA, IN, KS, KY, LA, MI, MN, NC, NY, OR, TX.
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.
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|---|---|---|---|---|---|
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