{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "123223",
      "product_res_number": "Z-0383-2014",
      "event_date_initiated": "2013-10-29",
      "event_date_posted": "2013-11-22",
      "recall_status": "Terminated",
      "event_date_terminated": "2014-03-17",
      "res_event_number": "66739",
      "product_code": "JJW",
      "k_numbers": [
        "K973451"
      ],
      "product_description": "MAS Urinalysis Control Level 1, Multi-analyte control (Assayed and Unassayed), Catalog/Part Numbers: 024222; Product is manufactured and distributed by Microgenics Corporation, a subsidiary of Thermo Fisher Scientific, Clinical Diagnostic Division, Fremont, CA\n\nMAS Urinalysis is intended for use in the clinical laboratory as a control for qualitative and semi-quantitative procedures used in routine urinalysis testing. Assay values are provided for specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and equipment. The product is suitable for use as a control material for physiochemical, chemical, and microscopic methods of routine urinalysis. Urinalysis may be used in conjunction with commercially available standardized systems for urine microscopic analysis.",
      "code_info": "Lot Number: UA1514011",
      "firm_fei_number": "3007002691",
      "recalling_firm": "Thermofisher Scientive",
      "address_1": "46360 Fremont Blvd",
      "city": "Fremont",
      "state": "CA",
      "postal_code": "94538-6406",
      "reason_for_recall": "Via one (1) consumer complaint and in-house testing has confirmed that the product does not meet the 30 day open vial stability specifications for Lot: UA1514011.",
      "root_cause_description": "Under Investigation by firm",
      "action": "ThermoFisher Scientific, sent an  Urgent Medical Device Field Correction letter dated October 29, 2013,  to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. \n\nCustomers were instructed to immediately discontinue use, segregate and discard the affected product. Customers with questions were instructed to contact mas.controls@thermofisher.com. For question regarding this recall call 1-800-232-3342.",
      "product_quantity": "914 units",
      "distribution_pattern": "Worldwide Distribution - USA (nationwide) including Puerto Rico and internationally to Hong Kong.",
      "openfda": {
        "k_number": [
          "K081908",
          "K831994",
          "K022085",
          "K992578",
          "K890577",
          "K891286",
          "K792376",
          "K771713",
          "K942853",
          "K830834",
          "K935062",
          "K781691",
          "K842366",
          "K780802",
          "K103387",
          "K972710",
          "K890534",
          "K973451",
          "K840618",
          "K880495",
          "K131444",
          "K792374",
          "K780482",
          "K861756",
          "K902699",
          "K931467",
          "K831526",
          "K031231",
          "K760863",
          "K863127",
          "K072640",
          "K992576",
          "K052242",
          "K770390",
          "K843565",
          "K934257",
          "K945913",
          "K991917",
          "K822540",
          "K981933",
          "K031441",
          "K070848",
          "K021155",
          "K884424",
          "K023928",
          "K943780",
          "K874890",
          "K952840",
          "K110846",
          "K170091",
          "K000874",
          "K810917",
          "K853603",
          "K043266",
          "K880496",
          "K142262",
          "K781961",
          "K042446",
          "K832713",
          "K852295",
          "K840848"
        ],
        "registration_number": [
          "",
          "3002637618",
          "9611444",
          "3010152370",
          "3003646592",
          "1832216",
          "3011310576",
          "1832816",
          "1827821",
          "9681576",
          "3003951180",
          "3010939897",
          "3003741796",
          "2432235",
          "3009448641",
          "2016706",
          "9613959",
          "1061932",
          "1219029",
          "2050010",
          "2027370",
          "2084170",
          "2084025",
          "3010421384",
          "3007701696",
          "3009711478",
          "1649661",
          "9615507",
          "2531491",
          "3010891909",
          "3003917514",
          "3010127294",
          "3004493545",
          "1616487",
          "2085064",
          "2020715",
          "2085402"
        ],
        "fei_number": [
          "",
          "3002637618",
          "3010152370",
          "3003646592",
          "3001451797",
          "1832216",
          "3011310576",
          "1832816",
          "1827821",
          "3003951180",
          "3010939897",
          "3003741796",
          "3000203293",
          "2432235",
          "3009448641",
          "3002807423",
          "2016706",
          "1219029",
          "2050010",
          "2027370",
          "2084170",
          "2084025",
          "3003516723",
          "3010421384",
          "3007701696",
          "3009711478",
          "1000519735",
          "3010891909",
          "3003917514",
          "3010127294",
          "3004493545",
          "1616487",
          "3002829675",
          "3002808301",
          "2020715",
          "3002546385",
          "1000135102"
        ],
        "device_name": "Urinalysis Controls (Assayed And Unassayed)",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1660",
        "device_class": "1"
      }
    }
  ]
}