{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "202632",
      "product_res_number": "Z-0038-2024",
      "event_date_initiated": "2023-08-30",
      "event_date_posted": "2023-10-05",
      "recall_status": "Open, Classified",
      "res_event_number": "92810",
      "product_code": "DOP",
      "product_description": "4500MD Triple Quad Mass Spectrometer, Part Number 5032522",
      "code_info": "UDI-DI: 00842365102049;\nSerial Numbers: EJ230051806PL, EJ230061807PL, EJ230071808, EJ230101810, EJ230111811, EJ230121811, EJ230141811, EJ230151812, EJ230161812, EJ230171901, EJ230181901, EJ230191901, EJ230211905, EJ230221908, EJ230231908, EJ230251909, EJ230271910, EJ230281910, EJ230311911, EJ230331912, EJ230362003, EJ230372003, EJ230392004, EJ230412009, EJ230422011, EJ230442012, EJ230452012, EJ230472101, EJ230482103, EJ230512105, EJ240012110, EJ240022111, EJ240052111, EJ240082207, EJ240092209, EJ240142307, EJ240132305, EJ240062201",
      "firm_fei_number": "3008935545",
      "recalling_firm": "AB Sciex, LLC",
      "address_1": "500 Old Connecticut Path",
      "city": "Framingham",
      "state": "MA",
      "postal_code": "01701-4574",
      "additional_info_contact": "877-740-2129",
      "reason_for_recall": "In rare occasions, the combination of a leak of a highly flammable solvent at the ion source probe, and an electrical discharge may result in a flame on top of the probe and possible ejection of the electrode assembly from the probe. There is a risk to the patient/user, customer property, or environment because there is a potential for a health risk and property damage should the flame be left unattended. The failure causes a delay in patient results.",
      "root_cause_description": "Component design/selection",
      "action": "An URGENT: RUO and MEDICAL DEVICE FIELD ACTION notification letter dated 7/20/23 was sent to customers.\n\nActions to be taken by the Customer/User:\nSCIEX will provide a replacement nut for eligible sources and systems. Instructions will be\nprovided to guide you through the replacement of the nut. The replacement parts with\ninstallation instructions are estimated to begin shipping in October 2023.\n\nSCIEX is currently notifying affected customers of the upcoming countermeasure.\nUpon availability, SCIEX will send you the replacement nut with instructions on how to\ninstall it on the ion source probe. We sincerely apologize for any inconvenience that this\nmay cause you. SCIEX aims to provide you with products of the highest quality.\n\nIf you have any questions regarding this notice, please contact https://sciex.com/aboutus/\ncontact-us or https://sciex.com/support/request-support.",
      "product_quantity": "38",
      "distribution_pattern": "US Nationwide.",
      "openfda": {
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          "K880418",
          "K810938",
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          "K880090",
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        ],
        "registration_number": [
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        "fei_number": [
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        ],
        "device_name": "Mass Spectrometer, Clinical Use",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.2860",
        "device_class": "1"
      }
    }
  ]
}