BEUDAMED
    FDA Recall Terminated

    ETEST IMIPENEM RELEBACTAM. in vitro diagnostic

    Recall: Z-2226-2021 · Initiated June 24, 2021

    Recall

    Recall Number
    Z-2226-2021
    Event Number
    88242
    Firm
    Biomerieux Inc
    FEI Number
    1950204
    Product Code
    JWY
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    June 24, 2021
    Terminated
    February 10, 2025
    Address
    595 Anglum Rd, Hazelwood, MO, 63042-2320

    Description

    ETEST IMIPENEM RELEBACTAM. in vitro diagnostic

    Reason

    Major errors (Resistant result instead of Susceptible result) were observed with Pseudomonas aeruginosa strains.

    Action

    The recall notification was issued to the impacted subsidiaries and distributors on 24JUN2021. The notification includes a Customer Letter to be translated into local language and sent to each impacted customer. The customer letter will inform the customers about the MIC overestimation and false resistant results issue and will be instructed to: - Perform a retest using an alternative method on P. aeruginosa strains for which they obtained resistant or intermediate results with ETEST IMIPENEM RELEBACTAM ref. 420925 and 420927 - Among tests previously performed, identify any possible false resistant/intermediate results that may have occurred, to analyze the related risks and to determine appropriate actions if relevant.

    Distribution

    Worldwide distribution - US Nationwide distribution including in the states of AR, AZ, CA, CO, DE, FL, GA, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI, WV and Hawaii. The countries of Austria, Belgium, Croatia, Czech Republic, France, Germany, Greece, Italy, Netherlands, Poland, Portugal, Spain, Sweden, Switzerland and United Kingdom.

    Quantity

    1,431