BEUDAMED
    FDA Recall Terminated

    VITEK 2 Antimicrobial Susceptibility Testing (AST) using one or more of these susceptibility products: Catalog # 410028, VITEK 2 AST-ST01 Catalog # 420915, VITEK 2 AST-ST02 Catalog # 421040, VITEK 2 AST-ST03 The VITEK 2 Streptococcus Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of S. pneumoniae, beta-hemolytic Streptococcus, and Viridans Streptococcus to antimicrobial agents when used as instructed.

    Recall: Z-0618-2019 · Initiated October 22, 2018

    Recall

    Recall Number
    Z-0618-2019
    Event Number
    81415
    Firm
    bioMerieux, Inc.
    FEI Number
    3002769706
    Product Code
    LON
    Status
    Terminated
    Root Cause
    Component change control
    Initiated
    October 22, 2018
    Terminated
    November 4, 2019
    Address
    100 Rodolphe St, Durham, NC, 27712-9402

    Description

    VITEK 2 Antimicrobial Susceptibility Testing (AST) using one or more of these susceptibility products: Catalog # 410028, VITEK 2 AST-ST01 Catalog # 420915, VITEK 2 AST-ST02 Catalog # 421040, VITEK 2 AST-ST03 The VITEK 2 Streptococcus Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of S. pneumoniae, beta-hemolytic Streptococcus, and Viridans Streptococcus to antimicrobial agents when used as instructed.

    Reason

    False resistant results for Streptococcus anginosus and Streptococcus constellatus strains were reported.

    Action

    The Firm, Biomerieux, issued a " URGENT Product Correction Notice" to their consignees informing of the matter and providing certain actions for them to take. Each Notice will be accompanied with an Acknowledge Form which is to be returned to bioMerieux.. The consignees were instructed to take the following action at this time: " Please confirm this letter has been distributed and reviewed by all appropriate personnel within your organization. " Reference your Laboratory Standard Operating Procedures to identify card types and breakpoints used in your facility to determine if your laboratory is impacted by the issue described in this letter. " Reference your Laboratory Standard Operating Procedures to identify if retrospective analysis is required for reported results associated with the referenced limitation. " For systems utilizing EUCAST breakpoints and operating with VITEK 2 Systems Software version 8.01, create a bioART Rule for the referenced limitation associated with Ceftriaxone (cro01n). " Please store this letter with your bioMrieux instrument documentation. -Please complete the attached Acknowledgement Form (Attachment A) and return it to bioMrieux, Inc. If you have any questions or concerns, please contact your local bioMrieux representative or call , Regulatory Quality Compliance Specialist, at 314-731-8805 or email: [email protected].

    Distribution

    Worldwide Distribution: US (nationwide) to states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI, WV, WY including Puerto Rico and to countries of:Algeria, Angola, Azerbaijan, Bahrain, Bangladesh, Belarus, Sarl, Benin, Bosnia-Herz, Cameroon, Chad, Cote d'Ivoire, Croatia, Dem. Rep. Congo, Egypt, , Georgia, Guam, Ethiopia, Iraq, Jordan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, UAB, Lithuania, Macedonia, Malta, Mongolia, Morocco, Mozambique, Niger, Oman, Pakistan, Palestine, Qatar, Romania, Saudi Arabia, Senegal, Serbia, Slovenia, Sri Lanka, Tunisia, Ukraine, Gabon, and Zimbabwe.

    Quantity

    184,374