Food, drugs, devices › Meridian Bioscience Inc
Device recall: Revogene SARS-CoV-2_IVD real-time RT-PCR test intended for the qualitative detection of RNA from SARSCoV-2 Catalog Numbe
FDA enforcement event 91356 is a device recall by Meridian Bioscience Inc of Cincinnati, OH, initiated 15 Dec 2022 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 839 device enforcement events initiated in 2022 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Meridian Bioscience Inc has 11 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Meridian Bioscience Inc, Cincinnati, OH.
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"
Distribution
"US Nationwide distribution in the states of AZ, CA, IN, KS, KY, LA, MI, MN, NC, NY, OR, TX."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1008-2023 | Revogene SARS-CoV-2_IVD real-time RT-PCR test intended for the qualitative detection of RNA from SARSCoV-2 Catalog Number: 410700 | 92 kits | Class II | Ongoing | 1 Feb 2023 |
Context
Other enforcement events for Meridian Bioscience Inc
All 11 events for Meridian Bioscience Inc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide distribution in the states of AZ, CA, IN, KS, KY, LA, MI, MN, NC, NY, OR, TX."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.