BEUDAMED
    FDA Enforcement Class II Ongoing

    BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.

    Recall: Z-2067-2026 · Reported May 13, 2026

    Enforcement

    Recall Number
    Z-2067-2026
    Event ID
    98776
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    BioFire Diagnostics, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 13, 2026
    Initiation Date
    April 22, 2026
    Classification Date
    May 6, 2026
    Address
    515 S Colorow Dr, Salt Lake City, UT, 84108-1248, United States

    Description

    BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.

    Reason

    Contamination to in-vitro diagnostic test may result in false positives.

    Code Info

    Lot #s:0883425,0878825/DI: 00815381020192

    Distribution

    Worldwide - US Nationwide distribution in the states of TX, NC, UT, MD and the countries of France, Italy, Germany, Spain, Belgium, Switzerland, United Kingdom, Netherlands, Poland, Austria, India, Finland, Czech Republic, Egypt, Lebanon, Morocco, Slovenia, Romania, Dominican Republic, Serbia.

    Quantity

    106 kits (3,180 test)