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

FDA device recall Z-1008-2023 · posted 2023-01-20 · Open, Classified

Recall details

Recalling firm

Meridian Bioscience Inc

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

Action taken

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.

Root cause

Process control

Status

Open, Classified

Product code

QJR

Quantity affected

92 kits

Distribution

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

Date initiated

2022-12-15

Date posted

2023-01-20

Location

Cincinnati, OH