{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "49194",
      "product_res_number": "Z-0228-2007",
      "event_date_initiated": "2006-09-05",
      "event_date_posted": "2006-12-06",
      "recall_status": "Terminated",
      "event_date_terminated": "2012-03-26",
      "res_event_number": "36707",
      "product_code": "JOZ",
      "k_numbers": [
        "K051231"
      ],
      "product_description": "VerifyNow P2Y12 Assay Device Kit, Part Number 85054",
      "code_info": "Lot Numbers: WK0002A , WK0003A,  WK0003B, WK0004A ,        WK0005A , WK0006A, WK0006AR, WK0006B, WK0006BR,         WK0007A, WK0008A, WK0009A, WK0010A ,WK0010B, 10WK000C, WK0011A, WK0012A and WK0013A",
      "firm_fei_number": "3001376288",
      "recalling_firm": "Accumetrics Inc",
      "address_1": "3985 B Sorrento Valley Blvd",
      "city": "San Diego",
      "state": "CA",
      "postal_code": "92121",
      "additional_info_contact": "Roberta G. Hoffman\n888-919-9333 Ext. 218",
      "reason_for_recall": "The VerifyNow P2Y12 assay can report an erroneous result instead of an error message when a sample with low hematocrit is run.",
      "root_cause_description": "Other",
      "action": "The 333 consignees were notified by regular mail or by E-mail on 9/5/2006 -- 9/13/2006. There were four versions of the notification letter tailored to (1) domestic customers; (2) domestic distributors; (3) international customers; and (4) international distributors. Each notification was accompanied by a 'fax back' form which customers were asked to sign and return to Accumetrics as an acknowledgement they received the notification letter.\n\nThe notification letter instructs consignees that test results with the VerifyNow P2Y12 Assay and all VerifyNow assays should be interpreted in conjunction with other clinical and laboratory data available to the clinician. Caution is advised when testing patients outside the ranges documented in the package insert.",
      "product_quantity": "333",
      "distribution_pattern": "Worldwide Distribution- USA, and countries of  Australia, Canada, France, Germany, Italy, Japan, Korea, Malaysia, Netherlands, New Zealand, Norway, Poland,  Singapore, Spain, Sweden, Switzerland, & United Kingdom",
      "openfda": {
        "k_number": [
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          "K012723",
          "K012701",
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          "K161329",
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          "K023761",
          "K141427",
          "K032951",
          "K191364",
          "K013596",
          "K163274",
          "K800146"
        ],
        "device_name": "System, Automated Platelet Aggregation",
        "medical_specialty_description": "Hematology",
        "regulation_number": "864.5700",
        "device_class": "2",
        "registration_number": [
          "1217183",
          "3002807408",
          "9610806",
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          "2518152",
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        ],
        "fei_number": [
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}