{
  "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": "176759",
      "product_res_number": "Z-0297-2020",
      "event_date_initiated": "2018-02-27",
      "event_date_created": "2019-11-05",
      "recall_status": "Open, Classified",
      "res_event_number": "83925",
      "product_code": "JBD",
      "k_numbers": [
        "K982426"
      ],
      "product_description": "SPIFE Alkaline Hemoglobin Kit, Cat. No. 3415,\n\n for use in the separation and quantitation of hemoglobins by agarose electrophoresis using the SPIFE systems",
      "code_info": "Lot Codes [Scheme:  62(nd lot)-(of 20)17-(for C/N)551977]: \"\tLot 62-17-551977  \"\tLot 63-17-551977  \"\tLot 64-17-551977  \"\tLot 65-17-551977  \"\tLot 66-17-551977  \"\tLot 67-17-551977  \"\tLot 68-17-551977  \"\tLot 69-17-551977  \"\tLot 70-17-551977  \"\tLot 71-17-551977  \"\tLot 72-17-551977  \"\tLot   1-18-551977,  \"\tLot   2-18-551977 \"\tLot   3-18-551977  \"\tLot   4-18-551977  \"\tLot   5-18-551977  \"\tLot   6-18-551977  \"\tLot   7-18-551977  \"\tLot   8-18-551977  \"\tLot   9-18-551977  \"\tLot 10-18-551977  \"\tLot 11-18-551977 \"\tLot 12-18-551977  \"\tLot 13-18-551977  The expiration date for all 2017-manufactured lots is 9/30/18. The expiration date for Lot 1 through Lot 11 of 2018 is 10/31/18.   The expiration date for Lot 12 and Lot 13 of 2018 is 12/31/18.",
      "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": "Lots of gel kits contained a newer revision of the Customer Procedures instructions than intended. The incorrect inserts refer to updated parameters associated with new electrodes -- which have not yet been made available to users.",
      "root_cause_description": "Labeling mix-ups",
      "action": "On 2/27/2018, Helena's Technical Services contacted customer via phone call. In addition, consignees were emailed the recall notification. During the call/ communicated the following \n\nWe would like to make you aware that you recently received a lot of SPIFE Alkaline Hemoglobin Gel kits, Catalog number 551977, which contained a revised procedural insert.  This procedural version was released earlier than intended. The kits affected include the following lots: \n\nIf you utilized the new testing parameters in the kit, the only noticeable effects would be increased pattern lengths, which would not affect quantitation or interpretation.  Please discard the procedural inserts included in the kit received, and replace with the attached procedural insert(s), which contain the same instructions you have historically used: \nThe incorrect inserts refer to updated parameters associated with new electrodes -- which have not yet been made available to users -- as well as several improvements in the SPIFE Alkaline Hemoglobin gels that we anticipate will be released in the near future.  \nAt that time, additional instructions and information regarding the change will be made available to you.  \n\nWe apologize for any inconvenience this may have caused.  Please contact Technical Services at 1-800-231-5663, EXT 1600 if you have any questions.",
      "product_quantity": "899 kits",
      "distribution_pattern": "US: OH, NY, MI, IN, IL, MS, TX, CT, NJ, KY, FL, MD, GA, PA, AZ, MO, VA, SC, LA, KS, WA, WI, \n\nOUS: Colombia, Brasil, Taiwan",
      "openfda": {
        "k_number": [
          "K780163",
          "K991362",
          "K800854",
          "K802884",
          "K830804",
          "K901143",
          "K800853",
          "K800855",
          "K802821",
          "K771649",
          "K931503",
          "K982426",
          "K810047",
          "K053571",
          "K813395",
          "K800856",
          "K791008",
          "K820518",
          "K781119",
          "K810919",
          "K931465",
          "K032862",
          "K780807",
          "K790944",
          "K791290",
          "K992199"
        ],
        "device_name": "System, Analysis, Electrophoretic Hemoglobin",
        "medical_specialty_description": "Hematology",
        "regulation_number": "864.7440",
        "device_class": "2",
        "registration_number": [
          "1618982",
          "8023024"
        ],
        "fei_number": [
          "6387",
          "1618982"
        ]
      }
    }
  ]
}