BEUDAMED
    FDA Recall 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 · Initiated March 14, 2018

    Recall

    Recall Number
    Z-1513-2018
    Event Number
    79514
    Firm
    BioFire Diagnostics, LLC
    FEI Number
    3002773840
    Product Code
    PEN
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    March 14, 2018
    Posted
    April 25, 2018
    Terminated
    October 24, 2018
    Address
    515 S Colorow Dr, Salt Lake City, UT, 84108-1248

    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.

    Action

    The recalling firm initiated the recall on several different dates and methods: Via email on 3/14/2018 with the letter dated 3/3/2018 attached, via USPS on 3/23/2018, and via FedEx between 3/24/2018 and 3/28/2018. The recalling firm conducted an expansion and issued letters dated 6/11/2018 via FedEx or USPS on 6/13/2018.

    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.