BEUDAMED
    FDA Recall Terminated

    Thermo SCIENTIFIC, Sensititre CMC7AFLF, Gram Negative IVD AST

    Recall: Z-0332-2023 · Initiated October 20, 2022

    Recall

    Recall Number
    Z-0332-2023
    Event Number
    91104
    Firm
    Remel Inc
    FEI Number
    1924669
    Product Code
    JWY
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    October 20, 2022
    Posted
    December 8, 2022
    Terminated
    September 30, 2024
    Address
    12076 Santa Fe Trail Dr, Lenexa, KS, 66215-3519

    Description

    Thermo SCIENTIFIC, Sensititre CMC7AFLF, Gram Negative IVD AST

    Reason

    An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus spp., Providencia spp., Morganella Morganii) when tested with doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam and aztreonam.

    Action

    The firm issued an "Urgent Medical Device Correction" notice to its consignees on 10/25/2022 by US mail. The notice explained the issue, risk to health, and notified the consignees of an update to the IFU, specifically, "to add limitations for Carbapenems (Imipenem, Doripenem, Meropenem, Ertapenem), Cefepime, Piperacillin/Tazobactam and Aztreonam added for users to "NOT REPORT" any result for each member of the Protea tribe (including Proteus spp., Providencia spp., Morganella Morganii) to address false susceptible results." Please complete and return the Required Customer Reply form via email to [email protected]. Please keep this notification on file. The notice needs to be passed on to all who need to be aware within your organization or to any organization where the potentially affected products have been transferred. This correction notification is being made and performed by the US agent, Remel Inc., on behalf of the Foreign Manufacturer of the affected product, Trek Diagnostic Systems Ltd., located in East Grinstead, UK. Trek Diagnostic Systems and Remel Inc., both part of Thermo Fisher Scientific, are investigating the root cause and will implement corrective actions to prevent future recurrence. If you have any questions, please contact our Technical Services Department at 800-255-6730 (US) or email [email protected].

    Distribution

    US Nationwide Distribution

    Quantity

    1647 units