BEUDAMED
    FDA Recall Completed

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

    Recall: Z-0854-2022 · Initiated February 22, 2022

    Recall

    Recall Number
    Z-0854-2022
    Event Number
    89699
    Firm
    Illumina, Inc.
    FEI Number
    3003218906
    Product Code
    PFF
    Status
    Completed
    Root Cause
    Device Design
    Initiated
    February 22, 2022
    Address
    5200 Illumina Way, San Diego, CA, 92122-4616

    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.

    Action

    On February 22, 2022 Illumina issued a "Urgent Field Safety" recall notice to all affected consignees via E-Mail. The firm issued an amended "Urgent Medical Device" recall notice on March 11, 2022 via email to provide consignees with additional information. In addition to notifying consignees about the recall, the firm asked consignees to take the following actions: 1. Complete the attached FSN2022-125 verification form to confirm receipt of the notification and return the form to Technical Support at [email protected] within 5 business days. 2. If you have not already sent Illumina the Verification Form attached to FSN2022-1215, please complete the attached copy of the form and return it to Technical Support at [email protected] within 5 business days. No additional action is required at this time 3. Please note, if an operator experiences an adverse event with the use of this product, user may report this to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

    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