{
  "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": "50420",
      "product_res_number": "Z-0594-2007",
      "event_date_initiated": "2007-02-15",
      "event_date_posted": "2007-03-13",
      "recall_status": "Terminated",
      "event_date_terminated": "2007-05-08",
      "res_event_number": "37356",
      "product_code": "GHH",
      "k_numbers": [
        "K993276"
      ],
      "product_description": "Clearview Simplify D-dimer, in vitro diagnostic for qualitative detection of D-dimer in human whole blood and plasma.  \nProduct No.  61100KVC\n10 test devices containing anti D-dimer monoclonal antibody and sheep anti-mouse antibody 1 x 2.6 mL buffer containing 0.9% sodium chloride and 0.05% sodium azide\n10 plastic pipettes\nWampole Laboratories\nInverness Medical Professional diagnostics group Manufactured by Agen Biomedical Ltd, Brisbane, QLD Australia.",
      "code_info": "Kit lot number: PX018A Test device batch number: 682-024 Catalog Number:  6100KVC Expiration date: 3/2008",
      "firm_fei_number": "3003764480",
      "recalling_firm": "Inverness Medical Professional Diagnostics",
      "address_1": "2 Research Way",
      "city": "Princeton",
      "state": "NJ",
      "postal_code": "08540-6628",
      "additional_info_contact": "Katrina Fielder\n609-627-8038",
      "reason_for_recall": "Lot PX018A is exhibiting a decrease in sensitivity affecting the qualitative result around the cut off.",
      "root_cause_description": "Other",
      "action": "Recall notification letters were sent to all customers on 2/14/07 by first class mail.",
      "product_quantity": "382 kits",
      "distribution_pattern": "Worldwide, including USA, Puerto Rico, and Canada.",
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          "K993276",
          "K842277",
          "K852848",
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          "K872360",
          "K920668"
        ],
        "device_name": "Fibrin Split Products",
        "medical_specialty_description": "Hematology",
        "regulation_number": "864.7320",
        "device_class": "2",
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