BEUDAMED
    FDA Recall Terminated

    ETEST ETP32 (Ertapenem) Ref. 531640, 531600, blister packaging ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria (Only 531640 was distributed in the United States)

    Recall: Z-2095-2017 · Initiated April 25, 2017

    Recall

    Recall Number
    Z-2095-2017
    Event Number
    76983
    Firm
    BioMerieux SA Chemin De L'Orme Marcy L'Etoile France
    FEI Number
    1000611339
    Product Code
    JWY
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    April 25, 2017
    Posted
    May 3, 2017
    Terminated
    February 24, 2022

    Description

    ETEST ETP32 (Ertapenem) Ref. 531640, 531600, blister packaging ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria (Only 531640 was distributed in the United States)

    Reason

    False susceptible results

    Action

    bioMerieux sent an Urgent Product Safety Correction Notice on April 25, 2017 to U. S. consignees. The letter requested that they provide the notice to all appropriate personnel in the laboratory, asking them to identify any possible False Susceptible results. The letter included a Acknowledgment Form to be returned. On this notice the consignee will indicate the number of kits discarded. For customers with questions please contact their local bioMerieux Customer Service representative.

    Distribution

    NATIONWIDE DISTRIBUTION TO AL, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, IL, IN, IA, KS, KY, LA, M, MA, MD, MI, MN, MS, MO, MT, NE, NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and WY

    Quantity

    3,238 units