{
  "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": "2026-09-03",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 2
    }
  },
  "results": [
    {
      "cfres_id": "221574",
      "product_res_number": "Z-2965-2026",
      "event_date_initiated": "2026-07-13",
      "event_date_posted": "2026-08-14",
      "recall_status": "Open, Classified",
      "res_event_number": "99447",
      "product_code": "LIP",
      "k_numbers": [
        "K091361"
      ],
      "product_description": "Siemens Healthineers\nImmulite 2000 Systems SYP Syphilis Screen\nREF:L2KSY2(D)/10471981\nIVD, RxOnly",
      "code_info": "Lot Code: D387/UDI: 00630414976891",
      "firm_fei_number": "3002806944",
      "recalling_firm": "Siemens Healthcare Diagnostics Products Ltd.",
      "address_1": "Glyn Rhonwy",
      "city": "Caernarfon",
      "country": "United Kingdom",
      "additional_info_contact": "Louise Mclaughlin\n+441286-879405",
      "reason_for_recall": "Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.",
      "root_cause_description": "Under Investigation by firm",
      "action": "On July 13, 2026, Siemens Healthineers issued a Urgent Medical Device Correction to affected consignees via FedEx. Siemens asked consignees to take the following actions: \n\n1. Review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable. \n2.Discontinue use and discard the affected kit lot.\n3. Review your current inventory to determine your laboratory s replacement needs and provide this information to Siemens Healthineers for reporting to the authorities.\n4. Complete and return the Field Correction Effectiveness Check Form attached to this letter within (30) days.\n5.Retain this letter with your laboratory records and forward this letter to those who may have received the affected product(s).",
      "product_quantity": "24 units",
      "distribution_pattern": "Worldwide - US Nationwide distribution in the states of FL, NJ, NY  and the countries of Austria, Azerbaijan, Belgium, Brazil, Chile, Colombia, Cura-ao, St.¿Eus Cyprus, France, Germany, Italy, Kazakhstan, Latvia, Lithuania, Netherlands, Romania, Russian¿Fed., Saudi¿Arabia, Slovakia, Slovenia, South¿Africa, Spain, U.A.E., Ukraine, United¿Kingdom, Uzbekistan.¿¿¿¿¿",
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        "registration_number": [
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        ],
        "device_name": "Enzyme Linked Immunoabsorption Assay, Treponema Pallidum",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.3830",
        "device_class": "2"
      }
    }
  ]
}