BEUDAMED
    FDA Enforcement Class II Completed

    Illumina NextSeq 550Dx, REF: 20005715, CE, IVD

    Recall: Z-0854-2022 · Reported April 6, 2022

    Enforcement

    Recall Number
    Z-0854-2022
    Event ID
    89699
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    Illumina, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 6, 2022
    Initiation Date
    February 22, 2022
    Classification Date
    March 31, 2022
    Address
    5200 Illumina Way, N/A, San Diego, CA, 92122-4616, United States

    Description

    Illumina NextSeq 550Dx, REF: 20005715, CE, IVD

    Reason

    There is a potential that the DNA sequence analyzer may short circuit shortly after disconnection and reconnection of circuit board or imaging module due to an insufficient reconnection of the ribbon cable. The short circuit results in the device being inoperable.

    Code Info

    Lot #s NDX550110 - NDX550843 ; UDI: (01)00816270020125

    Distribution

    US: PA, WA, CA, MI, FL, MD, AR, UT NC, Fl, IL, NE, NJ, TN, NY, IN, CO, GA, OK, TX, CT, SD, NM, VA, AL, LA, SC, WV, OR, IA, AZ, MN OUS: Australia Austria Belgium Chile China Denmark Finland France Germany Hungary Ireland Italy Japan Latvia Netherlands Norway Poland Portugal Romania Russian Federation Saudi Arabia Singapore Slovakia South Africa South Korea Spain Sweden Switzerland Turkey United Arab Emirates United Kingdom Vietnam

    Quantity

    674 instruments