{
  "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": "2026-04-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Beaumont",
      "address_1": "1530 Lindbergh Dr",
      "reason_for_recall": "Through an investigation, it has been determined that vials of Collagen packaged within the Collagen Reagent and  Platelet Aggregation Kit may contain particulate matter or microbial growth.",
      "address_2": "",
      "product_quantity": "383 Collagen Kits",
      "code_info": "Component Lot # 5-17-5368 (Collagen), Exp. 5/31/19  Kit Lot # 3-17-5369 (Aggregation kit containing Collagen),  Exp. 11/30/18  Kit Lot # 5-17-5368 (Aggregation Kit containing Collagen), Exp. 05/31/2019",
      "center_classification_date": "20191122",
      "distribution_pattern": "US:TX, WV, OH, TN, GA, TN, NY, ME, MA,LA, AZ  OUS: Israel, Korea, Australia, Indonesia, Canada, Thailand, Colombia, Brasil , China , Taiwan",
      "state": "TX",
      "product_description": "Platelet Aggregation Kit, Cat. No.5369, For use in platelet aggregation studies, Contains: 2X1 mL ADP Reagent containing adenosine diphosphate, 2X 1 mL Collagen Reagent containing collagen (equine tendon), 2 x 1 mL Epinephrine Reagent containing L-epinephrine, FOR IN-VITRO DIAGNOSTIC USE, Store at 2 to 8 C, 0011724/14(3)",
      "report_date": "20191204",
      "classification": "Class III",
      "openfda": {},
      "recalling_firm": "Helena Laboratories, Corp.",
      "recall_number": "Z-0536-2020",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "product_type": "Devices",
      "event_id": "83930",
      "more_code_info": "",
      "recall_initiation_date": "20180523",
      "postal_code": "77707-4131",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Ongoing"
    }
  ]
}