{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "35782",
      "product_res_number": "Z-0217-05",
      "event_date_initiated": "2004-10-27",
      "event_date_posted": "2004-11-20",
      "recall_status": "Terminated",
      "event_date_terminated": "2005-03-16",
      "res_event_number": "30388",
      "product_code": "LOL",
      "pma_numbers": [
        "P780012S007"
      ],
      "product_description": "IMx HAVAB Controls are for In Vitro Diagnostic use. The kit is composed of 2 bottles of Negative and Positive controls of 9 mL each. These are prepared with recalcified human plasma and the preservative is Sodium Azide. The Negative Control is non-reactive for HbsAG, HIV-1, Anti-HCV, anti-HiV-1/HIV-2 and IgG antibody against HAV. The Positive Control is recalcified human plasma for anti-HAV diluted with Negative Control.",
      "code_info": "Lot # 18220Q100 Exp. March 02, 2005",
      "firm_fei_number": "2623532",
      "recalling_firm": "Abbott Health Products, Inc.",
      "address_1": "Hwy 2 Km 58.0",
      "city": "Barceloneta",
      "postal_code": "00617",
      "country": "PR",
      "additional_info_contact": "Nydia I. Cancel\n787-846-3500",
      "reason_for_recall": "Abbott identified through investigational studies that IMx HAVAB Controls lot 18220Q100 is generating Negative Control values outside the upper range specified in the IMx HAVAB Package Insert.",
      "root_cause_description": "Other",
      "action": "Device recall letters were dated 10/27/2004.  Letter was mail to customers asking to destroy and discontinue use of device.  On hand inventory information was requested to be forward to Abbott at 1-800-777-0051 (U.S. only).",
      "product_quantity": "397 kits",
      "distribution_pattern": "The product has been distributed to hospitals, laboratories and other institution including government accounts.  Geographic areas of distribution include Puerto Rico, Canada, Germany, Thailand and U.S.A.\n\nGovernment accounts includes:  VA Medical Center, Saint Louise, MO; Brecksville VA Hosp. Supp, Brecksville, OH; VA MED CENTER, Phoenix, AZ; Department Veterinary Affair Med.,  Houston, TX; VA Med., Cincinnati, OH; VA Med Center, Seattle, WA; Truman Mem. VA, Columbia, MO; Dept. Vet. Aff., Shreveport, LA;  VA Hosp. Whse., Fresno, CA ; VA Med Center, Omaha, NE ; VA Med. Center, Lexington, KY; VA Med Center, Detroit, MI ; VA Hosp., San Diego, CA ; Naval Hosp., Great Lakes, IL; VA Med. Center, San Francisco, CA.",
      "openfda": {
        "k_number": [
          "K092355",
          "K222850",
          "K193532",
          "K100903",
          "K082050",
          "K060678",
          "K093955",
          "K260048",
          "K141116",
          "K190428",
          "K092353",
          "K060770",
          "K223403",
          "K142758",
          "K251995",
          "K103529",
          "K161964",
          "K081716",
          "K210272",
          "K082049",
          "K063329",
          "K063318",
          "K113704",
          "K063319",
          "K243846",
          "K160650"
        ],
        "pma_number": [
          "P830017",
          "P040017",
          "P790019",
          "P830018",
          "P780012",
          "P040018",
          "P890019",
          "P890014"
        ],
        "registration_number": [
          "2032682",
          "3012963943",
          "1319681",
          "3035708936",
          "8023018",
          "9680746",
          "3002809144",
          "2182595",
          "3005360469",
          "3004434309",
          "2029372",
          "9610126",
          "2250051",
          "9610240",
          "1219913",
          "2032839",
          "3007111389",
          "3002642396",
          "3005333358",
          "3002637618",
          "2432235",
          "3008576040",
          "3000308930",
          "3006198300",
          "8023060"
        ],
        "fei_number": [
          "3004185580",
          "3012963943",
          "3005670738",
          "3003952975",
          "3002807272",
          "3003992026",
          "3035708936",
          "3002809144",
          "2182595",
          "3004434309",
          "2250051",
          "3002806559",
          "1219913",
          "1000306617",
          "1000136573",
          "3007111389",
          "3002642396",
          "1000206808",
          "3005333358",
          "3002637618",
          "2432235",
          "3002808212",
          "3008576040",
          "3000308930",
          "3006198300"
        ],
        "device_name": "Hepatitis A Test (Antibody And Igm Antibody)",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.3310",
        "device_class": "2"
      }
    }
  ]
}