FDA Medical Device Recalls (openFDA)
Meridian Bioscience Inc: Revogene SARS-CoV-2_IVD real-time RT-PCR test intended for the qualitative detection of RNA from SARSCoV-2 Catalog Number: 410700
- Recall number
- Z-1008-2023
- Recalling firm
- Meridian Bioscience Inc
- Product
- Revogene SARS-CoV-2_IVD real-time RT-PCR test intended for the qualitative detection of RNA from SARSCoV-2 Catalog Number: 410700
- Status
- Open, Classified
- Initiated
- 2022-12-15
- Posted
- 2023-01-20
- Terminated
- not on file
- Reason
- 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
- Root cause
- Process control
- Action
- Meridian Bioscience issued Urgent Medical Device Recall on 12/15/22 via email. The letter states reason for recall, health risk and action to take: REQUIRED ACTIONS: " Inspect the rotor, ring, and chamber walls of the Revogene instrument for signs of leakage (e.g., dried spots). Contact Meridian Bioscience Technical Service if any signs of leakage were detected. " If leakage is suspected, clean the Revogene, MOCK PIEs, and surrounding workspace using the instructions in the Revogene operator's manual. " Review current inventory and segregate any remaining stock. " Discontinue use of any remaining stock. " Contact Meridian Technical Support 800.343.3858 to obtain a FedEx label to return any remaining inventory to Meridian Bioscience Inc. for credit. " Complete and return the Customer Notification Form. This will indicate receipt of this field correction notice. Complete this form even if you have no remaining inventory. Questions, please call Meridian Bioscience Technical Services at 1-800-343-3858, or email at MBI_TechService@meridianbioscience.com.
- Quantity
- 92 kits
- Distribution
- US Nationwide distribution in the states of AZ, CA, IN, KS, KY, LA, MI, MN, NC, NY, OR, TX.
- Lot, serial or model codes
- UDI: N/A Lot Numbers 410700P019, 410700P020, 410700P021, 410700P022, 410700P023, 410700P024, 410700P027
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- QJR
- Firm FEI
- 1524213
- Firm city
- Cincinnati
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28