{
  "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": "70968",
      "product_res_number": "Z-0514-2009",
      "event_date_initiated": "2007-06-01",
      "event_date_posted": "2009-01-17",
      "recall_status": "Terminated",
      "event_date_terminated": "2009-02-18",
      "res_event_number": "48190",
      "product_code": "JJW",
      "k_numbers": [
        "K874890"
      ],
      "product_description": "Quantimetrix Dip and Spin Control Urine Dipstick/Microscopics Control.\n\nThe intended use is to validate the performance of the Multistix, Chemstrip, Uriscan, QuickVue, Diascreen and other urinalysis reagent strips, and as a control for confirmatory tests such as Acetest, Clinitest, and Icotest reagent tablets, and as a control for hCG methods.  In addition, the Dip and Spin Control is intended as a means of validating the processing and centrifugation of patient urine samples prior to the microscopic evaluation of urine sediment.",
      "code_info": "Lot Numbers:  47160, 47170, 47180, 47190, 47200 and 47210.",
      "firm_fei_number": "2020715",
      "recalling_firm": "Quantimetrix Corporation",
      "address_1": "2005 Manhattan Beach Blvd",
      "city": "Redondo Beach",
      "state": "CA",
      "postal_code": "90278-1205",
      "additional_info_contact": "310-536-0006",
      "reason_for_recall": "This recall was initiated due to efficacy concerns with the stabilized erythrocytes, leukocytes and lymphocytes contained in this product group.",
      "root_cause_description": "Employee error",
      "action": "The recall communication was initiated when customer both direct and distributors who have purchased the lots were mailed a recall notification letter dated June 8, 2008 with instructions which was sent via first class mail.\n\nCustomers were requested to assist in the voluntary recall of the listed product and if any of the affected lots have been consumed please review their records to ensure that the obtained values conform to the stated specifications found in the lot specific product insert.",
      "product_quantity": "24,937 sets for all products.",
      "distribution_pattern": "Nationwide Distribution including states of AK, AR, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MN, MO, NC, ND, NH, NM, NY, OR, PA, SC, SD, TN, TX, VA, WA and WY.",
      "openfda": {
        "k_number": [
          "K852295",
          "K853603",
          "K890534",
          "K110846",
          "K170091",
          "K840618",
          "K042446",
          "K052242",
          "K952840",
          "K031441",
          "K991917",
          "K072640",
          "K822540",
          "K031231",
          "K000874",
          "K973451",
          "K810917",
          "K874890",
          "K891286",
          "K830834",
          "K780482",
          "K023928",
          "K972710",
          "K943780",
          "K890577",
          "K831994",
          "K021155",
          "K992578",
          "K131444",
          "K043266",
          "K935062",
          "K142262",
          "K770390",
          "K831526",
          "K931467",
          "K771713",
          "K781961",
          "K934257",
          "K022085",
          "K843565",
          "K832713",
          "K992576",
          "K981933",
          "K880496",
          "K945913",
          "K902699",
          "K760863",
          "K842366",
          "K861756",
          "K070848",
          "K942853",
          "K840848",
          "K781691",
          "K863127",
          "K884424",
          "K780802",
          "K103387",
          "K880495",
          "K081908",
          "K792376",
          "K792374"
        ],
        "registration_number": [
          "2432235",
          "1649661",
          "3010127294",
          "1219029",
          "2531491",
          "3010939897",
          "9613959",
          "1827821",
          "2084025",
          "1616487",
          "3002637618",
          "3010152370",
          "3010421384",
          "2085064",
          "3009448641",
          "9615507",
          "3047514284",
          "9681576",
          "3003741796",
          "1061932",
          "3011310576",
          "3007701696",
          "3009711478",
          "1832216",
          "2020715",
          "3010891909",
          "2084170",
          "2050010",
          "3004493545",
          "9611444",
          "2027370",
          "3003917514",
          "2085402",
          "1832816",
          "3003951180",
          "2016706",
          "3003646592"
        ],
        "fei_number": [
          "2432235",
          "3010127294",
          "1219029",
          "3002807423",
          "3000203293",
          "3003516723",
          "3010939897",
          "2084025",
          "1827821",
          "3003951180",
          "3001451797",
          "1616487",
          "3002637618",
          "3010152370",
          "3002546385",
          "1000519735",
          "3010421384",
          "3009448641",
          "1000135102",
          "3002829675",
          "3047514284",
          "3003741796",
          "3011310576",
          "3007701696",
          "3009711478",
          "1832216",
          "2020715",
          "3010891909",
          "2084170",
          "2050010",
          "3004493545",
          "2027370",
          "3003917514",
          "1832816",
          "3002808301",
          "2016706",
          "3003646592"
        ],
        "device_name": "Urinalysis Controls (Assayed And Unassayed)",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1660",
        "device_class": "1"
      }
    }
  ]
}