{
  "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": "2026-10-12",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 2
    }
  },
  "results": [
    {
      "cfres_id": "222721",
      "product_res_number": "Z-0001-2027",
      "event_date_initiated": "2026-09-03",
      "event_date_posted": "2026-10-10",
      "recall_status": "Open, Classified",
      "res_event_number": "99843",
      "product_code": "LCO",
      "k_numbers": [
        "K170854"
      ],
      "product_description": "HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009800127. in vitro diagnostic",
      "code_info": "Part Number: 0009800127.  UDI-DI: 08426951126545. Lot Number (Expiration Date): B40005 (01/16/2027), B38062 (11/01/2026).",
      "firm_fei_number": "1217183",
      "recalling_firm": "Instrumentation Laboratory",
      "address_1": "180 Hartwell Rd",
      "city": "Bedford",
      "state": "MA",
      "postal_code": "01730-2443",
      "additional_info_contact": "Keith Kelly\n732-3792123",
      "reason_for_recall": "Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples.",
      "root_cause_description": "Under Investigation by firm",
      "action": "Instrumentation Laboratory notified consignees on about 09/03/2026 via emailed and mailed URGENT MEDICAL DEVICE REALL letter.  Consignees were made aware of the issue and hazard involved. They were instructed to check inventory for affected lots, destroy any remaining product following each facility's standard procedures, and document the destruction on the enclosed Urgent Mandatory Response Tracking Form, including quantity destroyed and date of destruction.  Consignees were asked to identify an alternative method for HIT antibody testing as a supply interruption is expected and work local Werfen representatives for guidance and transition support.\n\nConsignees were also requested to 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 Urgent Mandatory Response Tracking Form within 10 days of receipt even if there is no remaining inventory.\n\nOn 09/29/2026, an expanded URGENT MEDICAL DEVICE RECALL Notification was sent to consignees through registered mail or email.  The updated notification informed consignees of additional lot numbers affected. Instructions remained the same.",
      "product_quantity": "434 units",
      "distribution_pattern": "Worldwide - US Nationwide distribution in the states of AR, AZ, CA, CT, FL, GA, MA, MD, NJ, NY, PA, RI, TN, WA, WV and the countries of Austria, Belgium, Switzerland, Costa Rica, Czech Republic, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, India, Italy, Jordan, Japan, South Korea, Luxembourg, Latvia, Netherlands, Saudi Arabia, Sweden, Singapore.",
      "openfda": {
        "k_number": [
          "K201570",
          "K243374",
          "K170854",
          "K201311",
          "K890633",
          "K040293",
          "K153137",
          "K071781",
          "K983379",
          "K003767",
          "K053559",
          "K071255",
          "K862774"
        ],
        "device_name": "Platelet Factor 4 Radioimmunoassay",
        "medical_specialty_description": "Hematology",
        "regulation_number": "864.7695",
        "device_class": "2",
        "registration_number": [
          "2183608",
          "2245451",
          "3037000637",
          "9710666",
          "9610746",
          "3004434070",
          "1217183"
        ],
        "fei_number": [
          "2183608",
          "2245451",
          "3037000637",
          "3003565434",
          "3002806557",
          "3004434070",
          "1217183"
        ]
      }
    }
  ]
}