BEUDAMED
    FDA Enforcement Class II Ongoing

    Cepheid, Sample Collection Device, Part: 900-0370

    Recall: Z-2584-2024 · Reported August 21, 2024

    Enforcement

    Recall Number
    Z-2584-2024
    Event ID
    94932
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Cepheid
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 21, 2024
    Initiation Date
    June 20, 2024
    Classification Date
    August 13, 2024
    Address
    904 E Caribbean Dr, Sunnyvale, CA, 94089-1189, United States

    Description

    Cepheid, Sample Collection Device, Part: 900-0370

    Reason

    Specimen collection device may leak after the patient sample swabs have been inserted into the test tubes, which could result in biohazard exposure, cross contamination causing false positive results for other specimens, and/or delay to test results.

    Code Info

    UDI-DI: 28053326001523. Lot/Expiration: 230397900/ July 3, 2024; 230535300/ July 14, 2024; 230627500/ August 4, 2024; 231877400/ April 10, 2025

    Distribution

    Worldwide distribution: US (nationwide): IL, TX, OH, LA, NY, CA, MD, IA, MN, KY, NH, WI, MO, NC, UT, WA, FL, NJ, SC, CO, PA, SD, NE, MT, WV, GA, MA, RI, CT, DE, MS, OK, VA, ID, AZ, OR, MI, IN, TN, AL, KS, ME, AR, NV, HI, AK, NM, WY, VT, ND, DC OUS (foreign) to countries of: Chile, Ireland, Oman, Nicaragua, Germany, San Marino, Ecuador, New Caledonia, France, Austria, United Kingdom, Finland, Italy, Hong Kong, Kuwait, United Arab Emirates, Netherlands, Belgium, Monaco, Colombia, Spain, Portugal, Poland, Switzerland, Denmark, Jersey, Mexico

    Quantity

    651,150