{
  "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": "189173",
      "product_res_number": "Z-0082-2022",
      "event_date_initiated": "2019-11-01",
      "event_date_created": "2021-10-08",
      "recall_status": "Terminated",
      "event_date_terminated": "2023-09-27",
      "res_event_number": "88652",
      "product_code": "LKJ",
      "k_numbers": [
        "K041658",
        "K113610"
      ],
      "product_description": "BioPlex 2200 ANA Screen Control Set, REF: 663-1131 incompatible with ANA Screen Reagent Packs/ANA Kits, REF: 665-1150; and ANA Screen Calibrator Sets, REF: 663-1101",
      "code_info": "REF: 663-1131, Lot: 51765, Expiration: 03/05/2021, and any subsequent lots incompatible with:\n\nREF: 665-1150, Lot-Expiration:\n300884-11/30/2019,\n300907-1/31/2020,\n300928-3/31/2020,\n300933-4/30/2020;\n\n\nand REF: 663-1101, Lot-Expiration:\n50661-11/30/2019,\n50726-3/11/2020,\n50835-3/27/2020,\n50858-5/1/2020",
      "firm_fei_number": "3008272466",
      "recalling_firm": "Bio-Rad Laboratories, Inc.",
      "address_1": "6565 185th Ave Ne",
      "city": "Redmond",
      "state": "WA",
      "postal_code": "98052-5039",
      "additional_info_contact": "425-881-8300",
      "reason_for_recall": "A new lot of ANA screen control and any subsequent control lots are incompatible with older lot numbers of ANA calibrators and ANA reagent packs.",
      "root_cause_description": "Process control",
      "action": "On 11/01/2019, ANA Screen Lot Matching-Compatibility Notice, were mailed to customers. Customers were advised of the following:\n\nIf you have received the new control material, please ensure that your laboratory is using one of the newer lot numbers of BioPlex ANA calibrators and ANA reagents. Should you have any of the older BioPlex ANA reagent packs and calibrator sets listed below in ITALICS\nremaining in your inventory or if you have used these lots in combination with the new control, please contact your local Technical Support center. The following telephone number was provided: 510-724-7000.",
      "product_quantity": "206",
      "distribution_pattern": "Worldwide distribution - U.S Nationwide distribution including in the states of CA, FL, NJ, IL, NE, TN, IN, TX, LA, WA, MI, MA, MN, OH, HI, MO, PA, CT, UT, SD, NY, AL, PR, OR, MD, KY, NC, AZ, SC, VA, WI, GA, IA, RI, AK, OK, KS, ND, MS, ME, NM, AR and the countries of ES, AE, DE, FR, KR, CN, TW, JP, IL, SG, AU, NZ, HK, IT, CA, PT, GB, NO, CZ, SE, CH, UA, RU, BE, DK.",
      "openfda": {
        "k_number": [
          "K873249",
          "K034013",
          "K954392",
          "K862313",
          "K913342",
          "K954891",
          "K030775",
          "K984473",
          "K842563",
          "K874115",
          "K021103",
          "K932679",
          "K082759",
          "K932876",
          "K883949",
          "K024223",
          "K993294",
          "K882740",
          "K024226",
          "K984464",
          "K864668",
          "K914454",
          "K894411",
          "K984478",
          "K831463",
          "K210902",
          "K961815",
          "K842484",
          "K883883",
          "K932302",
          "K113610",
          "K954723",
          "K011244",
          "K885224",
          "K920150",
          "K024218",
          "K921132",
          "K912291",
          "K893897",
          "K954700",
          "K041658",
          "K024232",
          "K042416",
          "K984470",
          "K893896",
          "K021257",
          "K984475",
          "K931255",
          "K081104",
          "K914550"
        ],
        "registration_number": [
          "2915274",
          "3004973408",
          "8043792",
          "9610566",
          "3003825930",
          "2242436",
          "2026994",
          "2918768",
          "3003935253",
          "3007208259",
          "3015376545",
          "1318354",
          "1181055",
          "3039353646",
          "3032705",
          "9680745"
        ],
        "fei_number": [
          "2915274",
          "3004973408",
          "3002808269",
          "3003825930",
          "2242436",
          "2026994",
          "2918768",
          "3007208259",
          "3005774014",
          "3015376545",
          "3002701146",
          "1318354",
          "1181055",
          "3039353646",
          "3002807876",
          "3003935253"
        ],
        "device_name": "Antinuclear Antibody, Antigen, Control",
        "medical_specialty_description": "Immunology",
        "regulation_number": "866.5100",
        "device_class": "2"
      }
    }
  ]
}