{
  "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": "209632",
      "product_res_number": "Z-0093-2025",
      "event_date_initiated": "2024-07-16",
      "event_date_posted": "2024-10-16",
      "recall_status": "Open, Classified",
      "res_event_number": "95159",
      "product_code": "JJW",
      "k_numbers": [
        "K072640"
      ],
      "product_description": "Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls, Catalog Number REF 800-7211 and 800-7702, in vitro diagnostic device.",
      "code_info": "UDI/DI 10837461002611, Lot Numbers:  432-24 and higher",
      "firm_fei_number": "3000203293",
      "recalling_firm": "Beckman Coulter, Inc.",
      "address_1": "11800 Sw 147th Ave",
      "city": "Miami",
      "state": "FL",
      "postal_code": "33196-2500",
      "additional_info_contact": "Jennifer Chau\n916-857-6006",
      "reason_for_recall": "Beckman Coulter has become aware of an increase in customer complaints for intermittent IRISpec CB negative glucose control failure, resulting in false positive control results when used in conjunction with iChemVELOCITY Urine Chemistry Strips (PNs 800-7204 and 800-7212) on the iChemVELOCITY Analyzer. This issue may delay the reporting of patient results, with a worst-case scenario of a delay in diagnosis or treatment of metabolic disorders, kidney function abnormalities, urinary tract infections, and liver function.",
      "root_cause_description": "Under Investigation by firm",
      "action": "Beckman Coulter issued an URGENT MEDICAL DEVICE RECALL notice to its consignees beginning on 07/15/2024 by letter delivered by either USPS first class mail or email.  The notice explained the issue, potential impact, and provided updated QC ranges for Glucose in the Analyzer.  The information is to be shared with all affected parties.  \nFor questions:  please contact Customer Support Center or your local representative;\nFrom our website: http://www.beckmancoulter.com\nBy phone: Call 800-526-7694 in the United States and Canada.\no Outside the United States and Canada, contact your local Beckman Coulter\nrepresentative.",
      "product_quantity": "5589 units",
      "distribution_pattern": "worldwide",
      "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"
      }
    }
  ]
}