BEUDAMED
    FDA Recall Terminated

    Verigene Processor SP with assay Luminex, VERIGENE Gram-Negative Blood Culture Nucleic Acid Test, BC-GN, IVD - Product Usage: utilizes a single-use disposable test consumables and a self-contained Verigene Test Cartridge for each sample tested.

    Recall: Z-2776-2020 · Initiated June 15, 2020

    Recall

    Recall Number
    Z-2776-2020
    Event Number
    85872
    Firm
    Luminex Corporation
    FEI Number
    3002524000
    Product Code
    PEN
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    June 15, 2020
    Terminated
    June 30, 2023
    Address
    12212 Technology Blvd, Austin, TX, 78727-6101

    Description

    Verigene Processor SP with assay Luminex, VERIGENE Gram-Negative Blood Culture Nucleic Acid Test, BC-GN, IVD - Product Usage: utilizes a single-use disposable test consumables and a self-contained Verigene Test Cartridge for each sample tested.

    Reason

    An instrument failure mode that may result in a Blood Culture Gram Positive (BC-GP) or Gram Negative (BC-GN) false negative call.

    Action

    On 06/10/2020, the firm sent a letter to customers titled, "MEDICAL DEVICE FIELD ACTION", regarding an instrument failure mode that may result in a Blood Culture Gram Positive (BC-GP) or Gram Negative (BC-GN) false negative call. The firm has developed a software solution that identifies and alerts users to the issue. The firm will contact customers to verify their address to ship the software material and provide installation information. Once the update has been completed, customers need to email a screen shot of the updated software, as well as a completed Notice of Destruction to Global Support Services at [email protected] to complete the upgrade process. The firm is also stating that until the updated software is installed, it is important, and part of good laboratory practice, that the customer follow the specific guidelines indicated in the current package inserts. Specifically, "Not Detected" test results from a positive blood culture should be evaluated further. The sub-culturing of blood cultures is necessary, per the intended use section within the Package Inserts in the Kits. For any questions contact the firm's Global Support Service at: 1.877.785.2323 (US) 1.512.381.4397 (OUS/CANADA) 512.219.5114 [email protected] www.luminexcorp.com

    Distribution

    Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CN, CT, DE, DC, FL,GA, ID, IN, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NB, NV, NE, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN TX, UT, VT, VA, WA, WV, WY, and WI. The countries of Austria, Belgium, Bulgaria, Canada, Chile, China, France, Germany, Greece, Hong Kong, Italy, Japan, Republic of Korea, Kuwait, Macau, Mexico, Netherlands, New Zealand, Republic of Russia, Saudi Arabia, Singapore, Spain, Thailand, Turkey, United Arab Emirate, and United Kingdom.

    Quantity

    Total = 3,016 systems (2240 Verigene Processor SP and 776 Verigene Processor SP Refurbished)