{
  "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,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "123688",
      "product_res_number": "Z-0482-2014",
      "event_date_initiated": "2013-11-14",
      "event_date_posted": "2013-12-11",
      "recall_status": "Terminated",
      "event_date_terminated": "2013-12-23",
      "res_event_number": "66834",
      "product_code": "JOZ",
      "k_numbers": [
        "K011337",
        "K013596",
        "K992531"
      ],
      "product_description": "VerifyNow IIb/IIIa Test, 10-Test Kit, Catalog No. 85310,\r\n\r\n10 tests/box; 690 total tests.\r\n\r\nThe VerifyNow IIb/IlIa Test is a semi-quantitative, whole blood platelet function test used to measure glycoprotein (GP) lIb/IlIa receptor blockade in patients treated with abciximab or eptifibatide. VerifyNow lIb/IlIa Test results should be interpreted in conjunction with other clinical and laboratory data available to the clinician. The VerifyNow System is a turbidimetric based optical detection system which measures platelet-induced aggregation. The system consists of an instrument, a disposable test device and quality control materials. The VerifyNow lIb/IlIa Test is a semi-quantitative, whole blood platelet function test used to measure glycoprotein (GP) lIb/IlIa receptor blockade in patients treated with abciximab or eptifibatide.",
      "code_info": "Lot No. WC0181H, WC0181J, WC0181K",
      "firm_fei_number": "3001376288",
      "recalling_firm": "Accumetrics Inc",
      "address_1": "3985 Sorrento Valley Blvd Ste B 3985 Sorrento Valley Blvd",
      "address_2": "Ste B",
      "city": "San Diego",
      "state": "CA",
      "postal_code": "92121-1497",
      "additional_info_contact": "858-643-1600",
      "reason_for_recall": "Accumetrics is recalling the VerifyNow IIb/IIIa 10-Test because it contains incorrect information for the amount of time in which to perform the test following collection of the patient sample.  The correct instruction is to perform the test within 15 minutes of collecting the patient sample.",
      "root_cause_description": "Other",
      "action": "Accumetrics sent an Urgent Medical Device Correction letter dated November 14, 2013 to end users for the VerifyNow IIb/IIIa 10-Test.  The letter informs the customers of the problems identified and the actions to be taken. The customers are instructed to call Accumetrics Customer Support at (800) 643-1640 option 2 or email at support@accumetrics.com.  Customers are instructed to complete and return the enclosed Customer Account Tracking Form as soon as possible.\r\nFor questions regarding this recall call 858-643-1600.",
      "product_quantity": "69 units",
      "distribution_pattern": "Nationwide Distribution including  NY, PA, DC, CT, IN, NJ, AR, TX, AZ,and NM.",
      "openfda": {
        "k_number": [
          "K140893",
          "K791577",
          "K002885",
          "K012723",
          "K962426",
          "K191364",
          "K954997",
          "K041502",
          "K060489",
          "K851669",
          "K032951",
          "K940792",
          "K012701",
          "K781807",
          "K800146",
          "K970505",
          "K770395",
          "K161329",
          "K011337",
          "K042423",
          "K862302",
          "K103555",
          "K050265",
          "K800432",
          "K990398",
          "K163274",
          "K013596",
          "K141427",
          "K051231",
          "K781693",
          "K760893",
          "K790769",
          "K780285",
          "K181777",
          "K992531",
          "K122162",
          "K023761",
          "K780047"
        ],
        "registration_number": [
          "3003601075",
          "8020030",
          "3005269352",
          "3003455467",
          "1219343",
          "3016571810",
          "2518152",
          "1618982",
          "3002807408",
          "3019849102",
          "1217183",
          "3016579901",
          "9610806",
          "3002721930",
          "1000487132",
          "3005739529",
          "3017875469"
        ],
        "fei_number": [
          "3003601075",
          "3005269352",
          "3003455467",
          "3001644026",
          "1219343",
          "2250033",
          "3016571810",
          "2518152",
          "1618982",
          "3002807408",
          "3019849102",
          "1217183",
          "3006461677",
          "3016579901",
          "1000487132",
          "3005739529",
          "3017875469"
        ],
        "device_name": "System, Automated Platelet Aggregation",
        "medical_specialty_description": "Hematology",
        "regulation_number": "864.5700",
        "device_class": "2"
      }
    }
  ]
}