Home / Recalls / Meridian Bioscience Inc / Z-1541-2021

Z-1541-2021 Class II Terminated

Recalled by Meridian Bioscience Inc — Cincinnati, OH

Recall Details

Product Type
Devices
Report Date
May 19, 2021
Initiation Date
April 8, 2021
Termination Date
October 26, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
124 Revogene RNA Software Upgrade Kits

Product Description

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

Reason for Recall

Emergency Use Application (EUA) application withdrawn as false negative results reported

Distribution Pattern

Nationwide

Code Information

All lot numbers

Other recalls by Meridian Bioscience Inc

  • Z-1019-2026 Class II — Revogene C. difficile, in vitro diagnostic assay intended for use with the Revog (December 5, 2025)
  • Z-0569-2026 Class II — Meridian Bioscience, Group B Streptococcus, Catalog Number 480050, Nucleic Acid (October 7, 2025)
  • Z-0568-2026 Class II — Meridian Bioscience, alethia c. Difficile, Catalog Number 480050, Nucleic Acid (October 7, 2025)
  • Z-0520-2024 Class II — Para-Pak Zn-PVA/10% Formalin-for the routine collection, transportation, preserv (October 19, 2023)
  • Z-0521-2024 Class II — Cardinal Health Clean Stool Transportation System-For the collection, transporta (October 19, 2023)
  • Z-0519-2024 Class II — Para-Pak Clean Vial-For the collection, transportation, preservation, and examin (October 19, 2023)
  • Z-1008-2023 Class II — Revogene SARS-CoV-2_IVD real-time RT-PCR test intended for the qualitative dete (December 15, 2022)
  • Z-1479-2022 Class II — Revogene, Catalog no. 610210. IVD test instrument (June 22, 2022)
  • Z-0836-2022 Class II — Revogene, For In Vitro Diagnostic use in performing nucleic acid testing in clin (February 15, 2022)
  • Z-1540-2021 Class II — Revogene SARS-CoV-2 Catalog Number: 410700 IVD for real-time Reverse Transc (April 8, 2021)