BEUDAMED
    FDA Recall Terminated

    VITEK 2 Gram Negative test kits containing colistin (cs01n)

    Recall: Z-2770-2017 · Initiated May 16, 2017

    Recall

    Recall Number
    Z-2770-2017
    Event Number
    77373
    Firm
    Biomerieux Inc
    FEI Number
    1950204
    Product Code
    PTJ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 16, 2017
    Posted
    June 27, 2017
    Terminated
    June 19, 2019
    Address
    595 Anglum Rd, Hazelwood, MO, 63042-2320

    Description

    VITEK 2 Gram Negative test kits containing colistin (cs01n)

    Reason

    The investigation demonstrated a high rate of very major errors (resistant isolates calling susceptible) with the VITEK 2 AST-GN colistin (cs01n) compared to agar dilution (the reference method used for cs01n development) and compared to broth-microdilution (recommended method by EUCAST/CLSI).

    Action

    Customers were notified on or about 05/16/2017 and then notified again with an updated letter. Instructions to customers included requesting that the attached acknowledgement form be completed, distribute the recall notification to customers, and provide the notice to future customers.

    Distribution

    Domestic: NC. Foreign: Argentina, Austria, Brazil, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, France, Germany, Guatemala, Hong Kong, India, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, Netherlands Antilles, Nicaragua, Panama, Paraguay, Peru, Philippines, Poland, Singapore, South Africa, South Korea, Spain, Thailand, Turkey, United Kingdom, Uruguay, Venezuela, & Vietnam.

    Quantity

    1,520,000 cards