BEUDAMED
    FDA Enforcement Class II Terminated

    Gram-Negative Bacteria And Associated Resistance Markers; Film Array Blood Culture Identification (BCID); Film Array BCID Panel - Product Usage: intended for use with FilmArray systems. Part No: RFIT-ASY-0126 / UDI: 00815381020086 Part No: RFIT-ASY-0127 / UDI: 00815381020093 IVD, Rx Only

    Recall: Z-1157-2021 · Reported March 10, 2021

    Enforcement

    Recall Number
    Z-1157-2021
    Event ID
    87282
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    BioFire Diagnostics, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 10, 2021
    Initiation Date
    January 26, 2021
    Classification Date
    March 1, 2021
    Termination Date
    May 2, 2022
    Address
    515 S Colorow Dr, Salt Lake City, UT, 84108-1248, United States

    Description

    Gram-Negative Bacteria And Associated Resistance Markers; Film Array Blood Culture Identification (BCID); Film Array BCID Panel - Product Usage: intended for use with FilmArray systems. Part No: RFIT-ASY-0126 / UDI: 00815381020086 Part No: RFIT-ASY-0127 / UDI: 00815381020093 IVD, Rx Only

    Reason

    The firm has identified an increased risk of false positive Pseudomonas aeruginosa when BCID/BCID2 Panels are used with specific BD BACTEC" blood culture vials.

    Code Info

    All non-expired BCID and BCID2 Panel lots, if used with the BD BACTEC Culture Media vials Catalog No. 442023 and 442020.

    Distribution

    Worldwide distribution - US Nationwide distribution and the countries of Afghanistan, Angola, Anguilla , Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Bolivia, Brazil, Brunei. Daruss., Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Cote d'Ivoire, Croatia, Czech Republic, Dominican Rep, Dutch Antilles, Ecuador, Egypt, El Salvador, Estonia, France, Georgia, Germany, Greece, Guam, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Latvia, Lebanon, Macedonia, Malaysia, Mexico, Morocco, Myanmar, Netherlands, Nicaragua, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Serbia, Singapore, Slovenia, South Korea, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, United Kingdom, Uruguay, Utd/Arab Emir/, Vietnam.

    Quantity

    21,922 kits