BEUDAMED
    FDA Recall Terminated

    bioMerieux VITEK 2 Gram Positive Cefoxitin Screen, VITEK 2 Gram Positive AST for Oxacillin, VITEK SYSTEMS General Susceptibility Card Cefotoxin and AST for Oxacillin bioMerieux VITEK 2 AST-P631 bioMerieux VITEK 2 AST-GP67 Test Kit bioMerieux VITEK 2 AST-GP71 Test Kit bioMerieux VITEK 2 AST-GP75 Test Kit bioMerieux VITEK 2 AST-GP78 Test Kit Components for an automated invitro diagnostic system consisting of instruments, software and reagent cards designed for the ID and antimicrobial susceptibility testing of bacteria and yeast.

    Recall: Z-2817-2018 · Initiated January 26, 2018

    Recall

    Recall Number
    Z-2817-2018
    Event Number
    80619
    Firm
    bioMerieux, Inc.
    FEI Number
    3002769706
    Product Code
    LON
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    January 26, 2018
    Posted
    August 30, 2018
    Terminated
    May 20, 2019
    Address
    100 Rodolphe St, Durham, NC, 27712-9402

    Description

    bioMerieux VITEK 2 Gram Positive Cefoxitin Screen, VITEK 2 Gram Positive AST for Oxacillin, VITEK SYSTEMS General Susceptibility Card Cefotoxin and AST for Oxacillin bioMerieux VITEK 2 AST-P631 bioMerieux VITEK 2 AST-GP67 Test Kit bioMerieux VITEK 2 AST-GP71 Test Kit bioMerieux VITEK 2 AST-GP75 Test Kit bioMerieux VITEK 2 AST-GP78 Test Kit Components for an automated invitro diagnostic system consisting of instruments, software and reagent cards designed for the ID and antimicrobial susceptibility testing of bacteria and yeast.

    Reason

    Customer reports indicated an increase in the rate of non-detected MRSA in association with the VITEK 2 AST-P631 product.

    Action

    bioMerieux sent an Urgent Product Correction Notice letter to their French customers on January 26, 2018. Customer letters in the Americas were sent August 21, 2018. The letters identified the affected product, problem, and actions to be taken. Customers should follow steps outlined in the letter and contact bioMerieux for any additional questions regarding these corrective actions. Note: the actions do not include removal of the product. For any questions or concerns, contact your local bioMerieux representative.

    Distribution

    Worldwide distribution. US nationwide including Puerto Rico, Bermuda, Brazil, Canada, China, Curacao, Costa Rica, Dominican Republic, Ecuador, France, Guatemala, Indonesia, Israel, Hong Kong, South Korea, South Africa, Mexico, Myanmar, Nicaragua, Peru, Philippines, Paraguay, Singapore, Thailand, El Salvador, and Vietnam.

    Quantity

    13,961,320 US