BEUDAMED
    FDA Enforcement Class II Ongoing

    Simplexa COVID-19 Direct, REF: MOL4150; including Reaction Mix, REF: MOL4150; with previous assay definition v2

    Recall: Z-1209-2023 · Reported March 15, 2023

    Enforcement

    Recall Number
    Z-1209-2023
    Event ID
    91504
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    DiaSorin Molecular LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 15, 2023
    Initiation Date
    January 30, 2023
    Classification Date
    March 3, 2023
    Address
    11331 Valley View St, Cypress, CA, 90630-5366, United States

    Description

    Simplexa COVID-19 Direct, REF: MOL4150; including Reaction Mix, REF: MOL4150; with previous assay definition v2

    Reason

    Direct amplification Discs , used with COVID-19 and Flu A/B & RSV assays, may leak and cause contamination, cross-contamination, invalid results, and error codes.

    Code Info

    UDI-DI: 20816101027020. Product REF/Lot/Reaction Mix REF/Lot: MOL4150/US13950/MOL4151/US14091, MOL4150/US14913/MOL4151/US14063, MOL4150/US13952/MOL4151/US14065, MOL4150/US13955/MOL4151/US14086, MOL4150/US13959/MOL4151/US14088, MOL4150/US13956/MOL4151/US14087, MOL4150/US13960/MOL4151/US14093, MOL4150/US13961/MOL4151/US14094, MOL4150/US13973/MOL4151/US13732, MOL4150/US13974/MOL4151/US13736, MOL4150/US14006/MOL4151/US13738, MOL4150/US14004/MOL4151/US15064, MOL4150/US14005/MOL4151/US13737, MOL4150/US14008/MOL4151/US14100, MOL4150/US14007/MOL4151/US14099, MOL4150/US14010/MOL4151/US14102, MOL4150/US14011/MOL4151/US14103, MOL4150/US14012/MOL4151/US15290, MOL4150/US14018/MOL4151/US14111, MOL4150/US14009/MOL4151/US14101, MOL4150/US14017/MOL4151/US14109, MOL4150/15061N/MOL4151/13474N, MOL4150/X15475N/MOL4151/X15479N, MOL4150/13330N/MOL4151/14829N, MOL4150/13331N/MOL4151/13751N, MOL4150/13336N/MOL4151/13752N, MOL4150/13968N/MOL4151/14036N, MOL4150/14346N/MOL4151/14038N, MOL4150/13967N/MOL4151/15082N

    Distribution

    US Nationwide distribution including in the states of NJ, ME, ND, IL, MI, FL, GA, AZ, MA, CA, MO, SD, MN, PA, OH, VT, NE, WI, CO, DC, VA, TX, NH, IN, IA, MD, NC, AL, NY, KY, WV, RI, KS, NM, OK, WA, SC, CT, TN, NV, LA.

    Quantity

    90142