BEUDAMED
    FDA Enforcement Class II Ongoing

    Xpert Xpress Strep A, XPRSTREPA-10, P/N: 302-2294 IVD, Rx Only

    Recall: Z-0215-2024 · Reported November 8, 2023

    Enforcement

    Recall Number
    Z-0215-2024
    Event ID
    93125
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Cepheid
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 8, 2023
    Initiation Date
    April 24, 2023
    Classification Date
    November 2, 2023
    Address
    904 E Caribbean Dr, N/A, Sunnyvale, CA, 94089-1189, United States

    Description

    Xpert Xpress Strep A, XPRSTREPA-10, P/N: 302-2294 IVD, Rx Only

    Reason

    pipettes packaged in Strep A test may fail to dispense an adequate sample volume which could result in "invalid" results or no result test results.

    Code Info

    UDI: (01)07332940006372/ Lots: 23718 23719 23720 10309 23201 23305 23308 23312 23314 23315 23401 23402 23403 23404 23405 23406 23407 23501 23504 23505 23506 23408 23410 23510 23411 23604 23605 23607 23608 23609 23610 23611 23612 23701 23702 23703 23705 23706 23707 23708 23709 23710 23711 23712 23714 23716 23717 23113 23316 23912 24112 23820 24704 24302 24307 24507 24508 24511 23822 23823 23824 24512 24513 24514 23825 24313 24515 24516 24517 24805

    Distribution

    Worldwide distribution - US Nationwide and the countries of Costa Rica, Ireland, Estonia, United Kingdom, Germany, Italy, Greece, Poland, Switzerland, Hong Kong, United Arab Emirates.

    Quantity

    89,958 kits ( 10 test per kit)