Meridian Bioscience Inc: Medical Device Recall in 2023 - (Recall #: Z-1008-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Revogene SARS-CoV-2_IVD real-time RT-PCR test intended for the qualitative detection of RNA from SARSCoV-2 Catalog Number: 410700

Product Classification:

Class II

Date Initiated: December 15, 2022

Date Posted: February 1, 2023

Recall Number: Z-1008-2023

Event ID: 91356

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

Status: Ongoing

Product Quantity: 92 kits

Code Information:

UDI: N/A Lot Numbers 410700P019, 410700P020, 410700P021, 410700P022, 410700P023, 410700P024, 410700P027

Distribution Pattern:

US Nationwide distribution in the states of AZ, CA, IN, KS, KY, LA, MI, MN, NC, NY, OR, TX.

Voluntary or Mandated:

Voluntary: Firm initiated