{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-12", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "cfres_id": "193602", "product_res_number": "Z-1259-2022", "event_date_initiated": "2022-05-03", "event_date_created": "2022-06-13", "recall_status": "Completed", "res_event_number": "90160", "product_code": "PFF", "product_description": "illumina REF DX-410-1001 Model: MiSeq Dx\n\nillumina REF 15036706 Model: MiSeq Dx\n\nillumina REF 20014053 Model: MiSeq Dx", "code_info": "Model Numbers:\nDX-410-1001;\n15036706;\n20014053;\n\nUDI-DI Code:\n00816270020002\n00816270020699\n\nAll Instruments containing Software version: v.1.3.1 to 3.0\n\nInstalled Product 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"firm_fei_number": "3003218906", "recalling_firm": "Illumina, Inc.", "address_1": "5200 Illumina Way", "city": "San Diego", "state": "CA", "postal_code": "92122-4616", "additional_info_contact": "Adi Raval\n202-629-8172", "reason_for_recall": "cybersecurity vulnerability", "root_cause_description": "Software in the Use Environment", "action": "On 05/03/2022, Illumina sent via email an \"Urgent Medical Device Recall\" Letter to customer informing them the cybersecurity vulnerability impacting the NextSeq 550 Dx and MiSeq Dx instruments with software versions 1.3 to 3.1 of the Local Run Manager (LRM) software installed.\n\nCustomers are also being informed that Illumina has developed a software patch to protect against the exploitation of the vulnerability. Installation of the software patch will block remote access to the LRM web User Interface (web UI).\nFor NextSeq 550Dx and MiSeq Dx instruments connected to the internet, the software\npatch is available for immediate download through a secure portal. Illumina is currently\nproviding the website address to impacted customers and regulatory authorities only.\nIllumina recommends that customers download and install the software patch on their\ninstrument(s) promptly.\nFor affected NextSeq 550Dx and MiSeq Dx instruments not connected to the internet,\nIllumina has developed other options for the installation of the software patch.\nImpacted customers should contact Tech Support promptly to obtain information about\nthese options.\nNextSeq 550Dx and MiSeq Dx instruments that have dual boot mode, the customers\nmust install the software patch separately in each mode (Dx mode and RUO mode) of\neach instrument. It is also important for the customer to install the software patch on\nany stand-alone instances of the off-instrument LRM for RUO mode on the Dx\ninstruments.\nIllumina will ask the customer to complete the Urgent Medical Device Recall\nverification form to confirm receipt of this notification and verify the patch was\ninstalled. We will ask the customer to return the form to Technical Support.\n\nFor questions, email - techsupport@illumina.com", "product_quantity": "1,014 instruments", "distribution_pattern": "Worldwide distribution - U.S. Nationwide distribution including in the states of AL, AZ, AR, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NE, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WI, and WV. The countries of Algeria, Australia, Austria, Belgium, Bulgaria, Bosnia/Herzegovina, Canada, Chile, \nChina, Cyprus, Czech Republic, Denmark, Egypt, Finland, France, Georgia, Germany, \nGuatemala, Hungary, Ireland, Italy, Japan, Latvia, Lithuania, Luxembourg, Macedonia, \nMalta, Morocco, Netherlands, New Zealand, Nigeria, Norway, Peru, Philippines, Poland, \nPortugal, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, \nSlovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, \nUkraine, United Arab Emirates, United Kingdom, Vietnam.", "openfda": { "k_number": [ "K170299", "DEN130011" ], "registration_number": [ "3015529000", "3007102730", "3014150341", "3003335080", "3006296346", "3003218906", "3007287152", "3009207631", "3003673482", "3011104381", "3009875001" ], "fei_number": [ "3015529000", "3007102730", "3014150341", "3003335080", "3003218906", "3007287152", "3009207631", "3003673482", "3005095756", "3011104381", "3009875001" ], "device_name": "High Throughput Dna Sequence Analyzer", "medical_specialty_description": "Immunology", "regulation_number": "862.2265", "device_class": "2" } } ] }