{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "San Diego",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "90508",
      "recalling_firm": "Alere San Diego, Inc.",
      "address_1": "9975 Summers Ridge Rd",
      "address_2": "",
      "postal_code": "92121-2997",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US: IL, NV, FL, LA, CA, MA, MN, NC, AK, NE, TX, PA, RI, SC, TN, OK, KY, GA, NY, MO, CO, AZ, OH, HI, VA, KS, IN, AL.    OUS: GB, ZA, NO, NL, FI, IE, IQ, IT, CH, DE, ES, HU, SI, NA, PT, IS, NG, PL, CY, TN, BH, ID, MY, AU, SG, JP, IN, BD, KR, HK, BR, CO, AR, CA",
      "recall_number": "Z-1508-2022",
      "product_description": "The Cholestech LDX¿ System combines enzymatic methodology and solidphase  technology to measure total cholesterol, HDL cholesterol, triglycerides and glucose. Samples  used for testing can be whole blood from a fingerstick (collected in a lithium heparin-coated capillary tube) or venipuncture. The sample is applied to an Cholestech LDX¿ cassette.    Description/Part: Cholestech LDX Lipid Profile GLU Cassette/10-991, 99021, 14-531;  Cholestech LDX TC HDL GLU Cassette/10-990;  Cholestech LDX Lipid Profile Cassette/10-989;  Cholestech LDX TC HDL Cassette/10-987",
      "product_quantity": "436,990",
      "reason_for_recall": "Cholesterol test cassettes package insert is to be updated with new bilirubin interference information because it was found that samples containing bilirubin, at concentrations greater than 2.0 mg/dL (conjugated) or 1.6 mg/dL (unconjugated), can result in low recovery of Triglyceride (TRG) and High-Density Lipoproteins (HDL).",
      "recall_initiation_date": "20220624",
      "center_classification_date": "20220806",
      "report_date": "20220817",
      "code_info": "All lots of Part/UDI-DI:  10-991/00893038002654,  99021/00899722002344,  14-531/04571226470831,  10-990/00893038002647,  10-989/00893038002630,  10-987/00893038002616",
      "more_code_info": ""
    }
  ]
}