{
  "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": "217761",
      "product_res_number": "Z-1095-2026",
      "event_date_initiated": "2025-12-11",
      "event_date_posted": "2026-01-15",
      "recall_status": "Open, Classified",
      "res_event_number": "98166",
      "product_code": "GFO",
      "k_numbers": [
        "K060688"
      ],
      "product_description": "The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of\nheparin therapy.",
      "code_info": "Part Number: 0020006800. \nUDI-DI:  08426950078920.\nLot Number: N1136730. \nExpiration Date 12/31/2025.",
      "firm_fei_number": "1217183",
      "recalling_firm": "Instrumentation Laboratory",
      "address_1": "180 Hartwell Rd",
      "city": "Bedford",
      "state": "MA",
      "postal_code": "01730-2443",
      "additional_info_contact": "Client Services\n752-379-2123",
      "reason_for_recall": "Potential for microbial contamination.",
      "root_cause_description": "Under Investigation by firm",
      "action": "Werfen notified consignees on about 12/11/2025 via URGENT MEDICAL DEVICE RECALL letter. Consignees were instructed to check inventory for affected lots and destroy any on hand, document any destruction on the provided Urgent Mandatory Tracking Form, inform all laboratory personnel of the notification, forward the notification to all affected departments and locations within each facility, retain a copy of the notification for records, and complete and return the Mandatory Response Tracking Form provided.",
      "product_quantity": "7,720 units",
      "distribution_pattern": "Worldwide - US Nationwide distribution in the states of CA, FL, IL, MN, MS, NE, OH, TX, WI and the countries of Belgium, Netherlands, Luxembourg, Switzerland, China, Hong Kong, Israel, Italy, South Korea, Lithuania, Macao, Malaysia, Philippines, Qatar, Romania, Turkey, Kosovo.",
      "openfda": {
        "k_number": [
          "K891015",
          "K924638",
          "K160445",
          "K900049",
          "K992712",
          "K961892",
          "K881068",
          "K891337",
          "K905301",
          "K924637",
          "K884702",
          "K911994",
          "K953981",
          "K992711",
          "K892209",
          "K022021",
          "K934351",
          "K760318",
          "K915418",
          "K903531",
          "K923731",
          "K060688",
          "K014008",
          "K014028",
          "K050221",
          "K895255",
          "K972831",
          "K884856",
          "K973306",
          "K253957",
          "K935169",
          "K882325",
          "K921223",
          "K955638",
          "K932011",
          "K053111",
          "K890859",
          "K884485",
          "K896545",
          "K193556",
          "K760918",
          "K890052",
          "K820835",
          "K904341",
          "K902556",
          "K915344",
          "K921396",
          "K781104",
          "K921118",
          "K890619",
          "K926012",
          "K955450"
        ],
        "device_name": "Activated Partial Thromboplastin",
        "medical_specialty_description": "Hematology",
        "regulation_number": "864.7925",
        "device_class": "2",
        "registration_number": [
          "3008386529",
          "3013660430",
          "1832216",
          "8043599",
          "1181121",
          "1217183",
          "3005146313",
          "2431530",
          "2245451",
          "9710666",
          "9610806",
          "3002721930",
          "1618982",
          "3003691680",
          "3037000637"
        ],
        "fei_number": [
          "3008386529",
          "3013660430",
          "2250033",
          "1832216",
          "1181121",
          "1217183",
          "3005146313",
          "2431530",
          "3005917516",
          "2245451",
          "3003565434",
          "3001644026",
          "1618982",
          "3003691680",
          "3037000637"
        ]
      }
    }
  ]
}