{
  "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": "2026-09-10",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "217753",
      "product_res_number": "Z-1084-2026",
      "event_date_initiated": "2025-12-15",
      "event_date_posted": "2026-01-14",
      "recall_status": "Open, Classified",
      "res_event_number": "98163",
      "product_code": "LCO",
      "k_numbers": [
        "K003767"
      ],
      "product_description": "Asserachrom HPIA. \nModel/Catalog Number: 00615.\n\nThe Asserachrom HPIA kit is intended for the qualitative detection in plasma or serum of the anti-heparin-platelet factor 4 (PF4) antibodies generated during the type II heparin-induced thrombocytopenia (HIT type II) by ELISA.",
      "code_info": "Reference Number: 00615. \nUDI: (01)03607450006155(11)240531(17)260531(10)271288(241)00615. \nLot Number: 271288.",
      "firm_fei_number": "2245451",
      "recalling_firm": "Diagnostica Stago, Inc.",
      "address_1": "5 Century Dr",
      "city": "Parsippany",
      "state": "NJ",
      "postal_code": "07054-4607",
      "additional_info_contact": "Technical Hotline\n800-7250607",
      "reason_for_recall": "Potential for defect for Asserachrom HPIA lot 271288, which can affect every well in the impacted strip and produce negative results.",
      "root_cause_description": "Under Investigation by firm",
      "action": "Diagnostica Stago notified consignees of the recall on about 12/15/2025 via email.   Consignees were instructed to stop using Lot 271288 and dispose of all remaining product according to local regulations, and complete, sign, and return the attached Acknowledgement Form provided. Additionally, consignees were instructed that if they have distributed the affected lot to any other laboratory, please notify those recipients\nof this recall and ask them to complete and return an Acknowledgement Form.",
      "product_quantity": "438 units",
      "distribution_pattern": "Worldwide - US Nationwide distribution in the states of AL, CA, FL, GA, HI, IA, MA, MI, NJ, NV, NY, OH, TN, WI and the countries of Belgium, Canada, Denmark, Algeria, Spain, Finland, France, Great Britain, Italy, Lebanon, Saudi Arabia, Uganda.",
      "openfda": {
        "k_number": [
          "K890633",
          "K071781",
          "K053559",
          "K153137",
          "K983379",
          "K201311",
          "K003767",
          "K201570",
          "K040293",
          "K862774",
          "K071255",
          "K243374",
          "K170854"
        ],
        "device_name": "Platelet Factor 4 Radioimmunoassay",
        "medical_specialty_description": "Hematology",
        "regulation_number": "864.7695",
        "device_class": "2",
        "registration_number": [
          "9610746",
          "3004434070",
          "1217183",
          "2245451",
          "9710666",
          "2183608",
          "3037000637"
        ],
        "fei_number": [
          "3002806557",
          "3004434070",
          "1217183",
          "2245451",
          "3003565434",
          "2183608",
          "3037000637"
        ]
      }
    }
  ]
}