BEUDAMED
    FDA Recall Open, Classified

    Thermo Scientific Sensititre Gram Negative Susceptibility Testing Plate, IVD format

    Recall: Z-0722-2022 · Initiated January 10, 2022

    Recall

    Recall Number
    Z-0722-2022
    Event Number
    89416
    Firm
    Remel Inc
    FEI Number
    1924669
    Product Code
    JWY
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    January 10, 2022
    Address
    12076 Santa Fe Trail Dr, Lenexa, KS, 66215-3519

    Description

    Thermo Scientific Sensititre Gram Negative Susceptibility Testing Plate, IVD format

    Reason

    There are lower than expected MICs for some gram negative species.

    Action

    A customer letter was issued to impacted consignees on or around 01/10/2022. Customers are asked to check for affected product and the recalling firm requests that customers do not report results of cefiderocol when affected product is used with Thermo Scientific Mueller-Hinton Broth with TES, catalong T3462, lots 267261 to 402775. Consignees are asked to disseminate the recall information within their organization and to any other organization to which affected products have been transferred. An acknowledgement form should be submitted by email to [email protected].

    Distribution

    Distribution throughout the United States.

    Quantity

    1210 devices