{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
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  },
  "results": [
    {
      "cfres_id": "211105",
      "product_res_number": "Z-0767-2025",
      "event_date_initiated": "2024-11-12",
      "event_date_posted": "2024-12-26",
      "recall_status": "Open, Classified",
      "res_event_number": "95751",
      "product_code": "JGJ",
      "k_numbers": [
        "K140790"
      ],
      "product_description": "Magnesium Flex reagent cartridge, 360 tests, Catalog Number: K3057; Siemens Material Number (SMN): 10445158;",
      "code_info": "Siemens Material Number (SMN): 10445158; Catalog Number: K3057; UDI-DI: 00842768015694; Lot numbers: 24057BB, 24064BC.",
      "firm_fei_number": "2517506",
      "recalling_firm": "Siemens Healthcare Diagnostics, Inc.",
      "address_1": "500 Gbc Dr",
      "city": "Newark",
      "state": "DE",
      "postal_code": "19702-2466",
      "additional_info_contact": "Beth Coolbaugh\n800-441-9250",
      "reason_for_recall": "Siemens Healthcare Diagnostics is recalling two lots of their Dimension Vista Total Magnesium (MG) Flex Reagent Cartridges (lots 24057BB and 24064BC) due to the potential for falsely low measurements of magnesium in plasma. Because the error is intermittent, existing quality control procedures may not recognize that a patients results are incorrect, and the results may be reported out",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "On November 12, 2024 URGENT MEDICAL DEVICE CORRECTION letters were sent to consignees. Customer Actions  Please review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable.  Discontinue use of and discard the lots listed above.  Review your inventory of these products to determine your laboratory s replacement needs and to provide information to Siemens Healthineers for reporting to the authorities.  Complete and return the Field Correction Effectiveness Check Form attached to this letter within thirty (30) days.  Please retain this letter with your laboratory records and forward this letter to those who may have received the product. Resolution Siemens Healthineers has introduced additional manufacturing process controls that have resolved this issue. We apologize for the inconvenience this situation may cause. If you have any questions, please contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative.",
      "product_quantity": "13,115 units (11,520 US, 1,595 ROW)",
      "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Denmark, France, Germany, Italy, Slovenia, Spain.",
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        "device_name": "Photometric Method, Magnesium",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1495",
        "device_class": "1"
      }
    }
  ]
}