BEUDAMED
    FDA Recall Open, Classified

    VERIGENE Processor SP - Product Usage: intended for processing and identifying nucleic acids utilizing gold nanoparticle probe technology.

    Recall: Z-1488-2021 · Initiated March 18, 2021

    Recall

    Recall Number
    Z-1488-2021
    Event Number
    87591
    Firm
    Luminex Corporation
    FEI Number
    3006028115
    Product Code
    PCH
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    March 18, 2021
    Address
    4088 Commercial Ave, Northbrook, IL, 60062-1829

    Description

    VERIGENE Processor SP - Product Usage: intended for processing and identifying nucleic acids utilizing gold nanoparticle probe technology.

    Reason

    Potential for a false-negative result for Vibrio parahaemolyticus, Salmonella, and/or Shigella spp when used with the VERIGENE Enteric Pathogens Nucleic Acid Test Kit.

    Action

    A customer advisory notice dated 03/18/2021. The Customer Advisory Notice recommends customers review their QC data to ensure passing results for all VERIGENE EP test targets, and to contact Luminex if any false negatives are observed for any targets within the past twelve months, in order to arrange for a replacement of the Amplification Heater. Additionally, if a Processor SP unit is indicated to have received service 15 on the TSB Log, the Amplification Heater would have already been replaced under routine maintenance with an in specification Amplification Heater and no further action is required for that instrument.

    Distribution

    Worldwide distribution - United States (nationwide) and the countries of Austria, France, Greece, Japan, Netherlands, Turkey.

    Quantity

    1210 Units