BEUDAMED
    FDA Enforcement Class II Terminated

    FilmArray BCID Panel (Blood Culture Identification Panel), Catalog numbers RFIT-ASY-0126 (30 test kit) and RFIT-ASY-0127 (6 test kit), when used with all lots of BD BACTEC Blood Culture Bottles, Catalog numbers 442020, 442021, 442023, 442192, 442265, 442194, 442022, 442193, 442260, and 442191.

    Recall: Z-1513-2018 · Reported May 2, 2018

    Enforcement

    Recall Number
    Z-1513-2018
    Event ID
    79514
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    BioFire Diagnostics, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 2, 2018
    Initiation Date
    March 14, 2018
    Classification Date
    April 25, 2018
    Termination Date
    October 24, 2018
    Address
    515 S Colorow Dr, N/A, Salt Lake City, UT, 84108-1248, United States

    Description

    FilmArray BCID Panel (Blood Culture Identification Panel), Catalog numbers RFIT-ASY-0126 (30 test kit) and RFIT-ASY-0127 (6 test kit), when used with all lots of BD BACTEC Blood Culture Bottles, Catalog numbers 442020, 442021, 442023, 442192, 442265, 442194, 442022, 442193, 442260, and 442191.

    Reason

    There is an increased risk of false positive Proteus results when the product is used with specific types of BD BACTEC blood culture bottles.

    Code Info

    All lot numbers are involved. UDI: 00815381020086 (RFIT-ASY-0126), 00815381020093 (RFIT-ASY-0127). The expiration dates of the BD BACTEC Blood Culture Bottles are 9/30/2018 and beyond.

    Distribution

    Distribution was nationwide. There was military/government distribution. Foreign distribution was made to Canada, Algeria, Argentina, Australia, Austria, Bahrain, Botswana, Brazil, Chile, Colombia, Costa Rica, Czech Republic, Dominican Republic, Ecuador, Egypt, France, French Polynesia, Georgia, Germany, Greece, Guatemala, Hong Kong, India, Iraq, Israel, Italy, Japan, Jordan, Republic of Korea, Kuwait, Lebanon, Malaysia, Mexico, Myanmar, The Netherlands, New Caledonia, Nicaragua, Panama, Peru, Republic of the Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, Uganda, United Arab Emirates, United Kingdom, Uruguay.

    Quantity

    N/A