{
  "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": "2026-10-07",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 4
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "San Diego",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "99409",
      "recalling_firm": "Alere San Diego, Inc.",
      "address_1": "9942 mesa rim rd",
      "address_2": "",
      "postal_code": "92121-2997",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "",
      "distribution_pattern": "Worldwide - US Nationwide distribution including in the states of IL, PA, FL, GA, VA, NY, TN, AZ, ID, ND, WI, AL, LA, NJ,MT, NE, OH, PR, IN, MI, WY, MA, CA, TX, HI, KS, KY, AR, CO, NC, WA, IA, MN, OK, OR, NM, SC, GU, MD, NV, MS, WV, SD, VT, DE and the countries of United Kingdom, Canada, Italy, Ireland, Spain, Portugal, New Zealand, Hong Kong, Australia, Papua New Guinea, Fiji, Guam, Sweden.",
      "recall_number": "Z-3272-2026",
      "product_description": "Fisher Scientific Sure-Vue Serum/Urine hCG, Model/ Part: FHC-202/23900529, FHC-202/23900528;    Beckman Coulter Inc's ICON 25 hCG, Model/ Part: FHC-202/43025;    Henry Schein One Step+ hCG Combo test in Serum or Urine, Model/ Part: FHC-202/9004075;    Alere hCG Combo Cassette (25mIU/mL) in Urine (CLIA Waived) or Serum, Model/ Part: FHC-202/92225;     Pro Advantage By NDC Urine/Serum Pregnancy Cassette Device, Model/ Part: FHC-202/P080021",
      "product_quantity": "5,331,585",
      "reason_for_recall": "hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.",
      "recall_initiation_date": "20260820",
      "center_classification_date": "20260925",
      "report_date": "20261007",
      "code_info": "All lots within the expiration date. Parts/UDI-DI/Labeling Versions Through: 23900529/00613647000540/1155810906, 2018-01-15; 23900528/00613647000564/1155810906, 2018-01-15; 43025/15099590776886/May 2015; 9004075/10304040024123/1155875804, 2014-06-09; 92225/10815845020116/1156015603, 07/16;  P080021/M220P0800213/40001856, 2023-03-30",
      "more_code_info": ""
    }
  ]
}