BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-2067-2026 · Initiated April 22, 2026

    Recall

    Recall Number
    Z-2067-2026
    Event Number
    98776
    Firm
    BioFire Diagnostics, LLC
    FEI Number
    3002773840
    Product Code
    QSN
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    April 22, 2026
    Posted
    May 6, 2026
    Address
    515 S Colorow Dr, Salt Lake City, UT, 84108-1248

    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.

    Action

    On April 22, 2026, bioMerieux issued a Urgent Medical Device Recall notification to affected consignees via E-Mail. bioMerieux asked consignees to take the following actions: 1 Examine your inventory for the lots identified in this recall notification. 2 Discontinue use and discard any remaining product from this lot in your possession. 3 Please confirm the quantity of kits that have been destroyed, previously used, or returned on the attached Acknowledgement of Receipt Form. 4 If the product has been transferred to another facility, please notify the facility and appropriate personnel. 5 If you have further distributed this product, please identify any recipients and notify them at once. 6 Please complete the accompanying Acknowledgement of Receipt Form and return to bioMrieux so that bioMrieux may acknowledge your receipt of this notification.

    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)