{
  "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": "184141",
      "product_res_number": "Z-0321-2021",
      "event_date_initiated": "2020-10-09",
      "event_date_created": "2020-10-31",
      "recall_status": "Terminated",
      "event_date_terminated": "2021-11-04",
      "res_event_number": "86598",
      "product_code": "GKA",
      "k_numbers": [
        "K955283"
      ],
      "product_description": "Ultra2 Resolution Variants System for Abnormal Hemoglobin Quantitation",
      "code_info": "Product Name and Product Code  ultra2 Resolution Variants Analyzer / 03-01-0047 ultra2 Resolution Analytical Column / 01-05-0011 Resolution Analytical Column /  01-05-0015 FASC Position Marker / 01-04-0042 A2+F Control Material Kit / 01-04-0043 Mobile Phase 1 Reagent 3.8L / 01-03-0040 Mobile Phase 1 Reagent 940mL / 01-03-0042 Mobile Phase 2 Reagent 3.8L / 01-03-0041 Mobile Phase 2 Reagent 940mL / 01-03-0044 2 Diluent Reagent 3.8L / 01-03-0056 2 Diluent Reagent 940mL / 01-03-0059 System Wash Reagent / 01-03-0035  Analyzer Unit serial numbers: 100242\t100314\t100331\t100354\t100468\t100541\t100638\t100746 100243\t100316\t100332\t100355\t100485\t100551\t100639\t100747 100244\t100317\t100334\t100356\t100492\t100558\t100644\t100751 100245\t100319\t100335\t100357\t100501\t100559\t100645\t100758 100300\t100321\t100337\t100358\t100503\t100561\t100654\t100765 100301\t100322\t100338\t100359\t100507\t100562\t100660\t100802 100304\t100323\t100342\t100360\t100508\t100563\t100664\t 100305\t100324\t100343\t100361\t100510\t100572\t100666\t 100306\t100325\t100344\t100404\t100515\t100574\t100683\t 100309\t100326\t100345\t100411\t100518\t100587\t100729\t 100310\t100327\t100348\t100416\t100527\t100590\t100730\t 100312\t100329\t100351\t100427\t100531\t100627\t100743\t 100313\t100330\t100353\t100446\t100533\t100633\t100745",
      "firm_fei_number": "1931251",
      "recalling_firm": "Primus Corporation",
      "address_1": "4231 E 75th Ter",
      "city": "Kansas City",
      "state": "MO",
      "postal_code": "64132-2059",
      "additional_info_contact": "Lupe Kagan\n760-473-7273",
      "reason_for_recall": "The product did not receive pre-market approval or clearance.",
      "root_cause_description": "No Marketing Application",
      "action": "Recall letters have been sent to US consignees via Federal Express Priority Overnight delivery.  \n\nCustomers were advised to transition to alternate testing methods and qualify a replacement device by March 7, 2021. During the transition, consumables will be made available for use but must be destroyed upon return of the analyzer.   Customers were also instructed to agree to the above requirements and return a Fax Back Form confirming compliance.  \n\nFollow-up will be conducted with consignees that do not reply to the recall notification.",
      "product_quantity": "97 devices (USA only)",
      "distribution_pattern": "US - Arizona, California, District of Columbia, Florida, Georgia, Illinois, Louisiana, Massachusetts,\nMichigan, Missouri, Nebraska, New Jersey, Nevada, New York, Pennsylvania, Rhode Island, Tennessee, Texas, Virginia, Wisconsin\nOUS - Bahrain, Iran, Malaysia, Saudi Arabia, Taiwan, Turkey, UAE, UK, Vietnam",
      "openfda": {
        "k_number": [
          "K051072",
          "K112550",
          "K924813",
          "K091283",
          "K052291",
          "K834595",
          "K955355",
          "K040146",
          "K050709",
          "K180762",
          "K822123",
          "K082227",
          "K820573",
          "K112491",
          "K232027",
          "K222635",
          "K080911",
          "K954048",
          "K955283",
          "K811894",
          "K192931",
          "K840011",
          "K171664"
        ],
        "device_name": "Abnormal Hemoglobin Quantitation",
        "medical_specialty_description": "Hematology",
        "regulation_number": "864.7415",
        "device_class": "2",
        "registration_number": [
          "2915274",
          "3005360469",
          "3032069621",
          "1000487132",
          "3003795116",
          "1931251",
          "8043909",
          "9610126",
          "1618982",
          "8023024"
        ],
        "fei_number": [
          "2915274",
          "3002808498",
          "3002806559",
          "3032069621",
          "1000487132",
          "3005670738",
          "3003795116",
          "1931251",
          "6387",
          "1618982"
        ]
      }
    }
  ]
}