{
  "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": "2026-09-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 2
    }
  },
  "results": [
    {
      "cfres_id": "176768",
      "product_res_number": "Z-0536-2020",
      "event_date_initiated": "2018-05-23",
      "event_date_created": "2019-11-22",
      "recall_status": "Open, Classified",
      "res_event_number": "83930",
      "product_code": "GHR",
      "k_numbers": [
        "K910706"
      ],
      "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)",
      "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",
      "firm_fei_number": "1618982",
      "recalling_firm": "Helena Laboratories, Corp.",
      "address_1": "1530 Lindbergh Dr",
      "city": "Beaumont",
      "state": "TX",
      "postal_code": "77707-4131",
      "additional_info_contact": "Dr. Jessica Jones Hanka\n409-842-3714 Ext. 1177",
      "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.",
      "root_cause_description": "Unknown/Undetermined by firm",
      "action": "On 05/23/2018, the firm's technical services contacted consignees via phone call with a email follow-up  of their recall notification letter.  Consignees were advised of the following:\n\n1. Prevent any shipment or schedule demonstrations with these lots\n2. Remove the lots from available inventory and discard COLLAGEN vials.\n3. Verify amount REMOVED FROM STOCK\n4. COMPLETE THE FORM AND RETURN TO HELENA LABORATORIES, USA VIA: fax: 409-842-1874 OR E-MAIL TO JJONES@HELENA.COM. For questions, contact Jessica W. Jones, MD, MPH - Mgr., Technical Services at: 1 (409) 842-3714 ext. 1177",
      "product_quantity": "383 Collagen Kits",
      "distribution_pattern": "US:TX, WV, OH, TN, GA, TN, NY, ME, MA,LA, AZ\nOUS: Israel, Korea, Australia, Indonesia, Canada, Thailand, Colombia, Brasil , China , Taiwan",
      "openfda": {
        "registration_number": [
          "1618982",
          "2518152",
          "3008386529",
          "2245451"
        ],
        "fei_number": [
          "1618982",
          "2518152",
          "3008386529",
          "2245451"
        ],
        "k_number": [
          "K952252",
          "K910800",
          "K910680",
          "K760198",
          "K910286",
          "K061991",
          "K922800",
          "K910706",
          "K832428",
          "K900792",
          "K820422"
        ],
        "device_name": "Reagent, Platelet Aggregation",
        "medical_specialty_description": "Hematology",
        "regulation_number": "864.5700",
        "device_class": "2"
      }
    }
  ]
}