{
  "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": "72823",
      "product_res_number": "Z-0171-2009",
      "event_date_initiated": "2008-08-25",
      "event_date_posted": "2008-10-22",
      "recall_status": "Terminated",
      "event_date_terminated": "2009-11-27",
      "res_event_number": "49131",
      "product_code": "CIT",
      "k_numbers": [
        "K941132"
      ],
      "product_description": "Liquid AST (SGOT) Reagent Set, Manufactured by Pointe Scientific, Inc., Canton, MI in 150 ml (Product no. A7561-150) and 450 ml (Product no A7561-450).  For the quantitative determination of aspartate amoinotransferase in human serum",
      "code_info": "A7561-150 lots 728504-046 and 728504-094.   A7561-450 lot 728504-063.  Exp. 4/09.",
      "firm_fei_number": "1827821",
      "recalling_firm": "Pointe Scientific, Inc.",
      "address_1": "5449 Research Dr",
      "city": "Canton",
      "state": "MI",
      "postal_code": "48188-2261",
      "additional_info_contact": "734-487-8300",
      "reason_for_recall": "The R1 component may be contaminated with Serratia liquefaciens, resulting decreased absorbances and failure of the reagent to produce test results.",
      "root_cause_description": "Material/Component Contamination",
      "action": "Consignees were notified via recall letter dated 8/22/08 and mailed 8/25/08 to examine their inventory, dispose of any recalled product found, and to notify the firm for replacements.  Contact Pointe Scientific Inc., at 1-800-757-5313 for assistance.",
      "product_quantity": "109 kits",
      "distribution_pattern": "Nationwide, Bolivia, Ecuador, Greece, Indonesia, Mexico, Nepal, Philippines, Romania and Serbia.",
      "openfda": {
        "k_number": [
          "K812592",
          "K983131",
          "K852783",
          "K780039",
          "K885156",
          "K821467",
          "K965126",
          "K924244",
          "K980902",
          "K080485",
          "K925155",
          "K871780",
          "K951751",
          "K013698",
          "K935181",
          "K821433",
          "K896229",
          "K842245",
          "K980666",
          "K961114",
          "K864813",
          "K810390",
          "K790483",
          "K934413",
          "K880276",
          "K870077",
          "K884377",
          "K981843",
          "K922108",
          "K981221",
          "K990009",
          "K001679",
          "K974001",
          "K863094",
          "K071525",
          "K896233",
          "K841066",
          "K830958",
          "K780443",
          "K981225",
          "K800688",
          "K780634",
          "K980030",
          "K863054",
          "K810727",
          "K896000",
          "K944102",
          "K992801",
          "K891468",
          "K892844",
          "K880692",
          "K071211",
          "K790017",
          "K760193",
          "K915555",
          "K901104",
          "K781020",
          "K840706",
          "K860667",
          "K791679",
          "K920336",
          "K954839",
          "K093883",
          "K813405",
          "K851994",
          "K760010",
          "K854982",
          "K800116",
          "K894180",
          "K803216",
          "K791080",
          "K992136",
          "K023551",
          "K071580",
          "K820270",
          "K864357",
          "K863963",
          "K780463",
          "K914068",
          "K821208",
          "K801856",
          "K800641",
          "K842521",
          "K932049",
          "K863257",
          "K952743",
          "K801118",
          "K875071",
          "K971344",
          "K860465",
          "K861656",
          "K903829",
          "K905771",
          "K781784",
          "K954992",
          "K800065",
          "K842411",
          "K884724",
          "K060318",
          "K941132",
          "K874600",
          "K870246",
          "K791082",
          "K851267",
          "K991663",
          "K772029",
          "K781725",
          "K923505",
          "K993468",
          "K854503",
          "K780103",
          "K843109",
          "K903197",
          "K897165",
          "K914463",
          "K851865",
          "K770318",
          "K914025",
          "K981650",
          "K780013",
          "K802447",
          "K872829",
          "K780505",
          "K922857",
          "K013145",
          "K822493",
          "K864302",
          "K896228",
          "K010488",
          "K792208",
          "K922885",
          "K861283",
          "K771153",
          "K893692",
          "K862832",
          "K923641",
          "K860725",
          "K843333",
          "K821876"
        ],
        "registration_number": [
          "",
          "2432235",
          "1319809",
          "1220972",
          "2050012",
          "3018771894",
          "3006716639",
          "3013660430",
          "1827821",
          "3002642396",
          "3002809144",
          "3006198300",
          "1616487",
          "1000403749",
          "3011989923",
          "1063851",
          "3014607865",
          "2939693",
          "9610126",
          "3007662974",
          "3009473156",
          "2085064",
          "1181121",
          "2250051",
          "9680746",
          "3003741796",
          "2517506",
          "2247288",
          "3016438761",
          "3005146313",
          "8030478",
          "1832216",
          "3021841051",
          "3000308930",
          "3005094123",
          "3000148879",
          "3003593973",
          "3005333358",
          "1319681",
          "2050010",
          "3014325803",
          "3012963943",
          "1717966",
          "2030861",
          "8020316",
          "9610529",
          "8040374",
          "3004493545",
          "3010825766",
          "3004438098",
          "3003795116"
        ],
        "fei_number": [
          "",
          "2432235",
          "3002806559",
          "1220972",
          "1000206808",
          "3002806809",
          "2050012",
          "3018771894",
          "3006716639",
          "3013660430",
          "1827821",
          "3002642396",
          "3002809144",
          "3006198300",
          "3000215862",
          "1616487",
          "1000403749",
          "3011989923",
          "3014607865",
          "2939693",
          "3001576181",
          "3007662974",
          "3009473156",
          "3002806560",
          "1000135102",
          "1181121",
          "2250051",
          "5864",
          "3003741796",
          "1000136573",
          "2517506",
          "3016438761",
          "3005146313",
          "1832216",
          "3021841051",
          "1000305840",
          "3000308930",
          "3005094123",
          "3000148879",
          "3003593973",
          "3005333358",
          "2050010",
          "1000122044",
          "3014325803",
          "3012963943",
          "1717966",
          "3004493545",
          "3010825766",
          "1000442352",
          "3004438098",
          "3003795116"
        ],
        "device_name": "Nadh Oxidation/Nad Reduction, Ast/Sgot",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1100",
        "device_class": "2"
      }
    }
  ]
}