{
  "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,
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  },
  "results": [
    {
      "cfres_id": "153381",
      "product_res_number": "Z-1684-2017",
      "event_date_initiated": "2017-02-23",
      "event_date_posted": "2017-03-08",
      "recall_status": "Open, Classified",
      "res_event_number": "76501",
      "product_code": "GIM",
      "k_numbers": [
        "K080552"
      ],
      "product_description": "Cyto-Chex BCT - blood specimen collection device - Immunophenotyping Preservative. IVD. Sterile. 2.0ml only.  Packaged 6-tube pack REF 213559 and 100-tube box REF 218980. Streck.",
      "code_info": "UDI Number 10844509000836 and 20844509000833.  Lot(s)                    Expiration Date 50910309             04-01-2017 60760309             03-16-2018 61460309             05-25-2018",
      "firm_fei_number": "1950302",
      "recalling_firm": "Streck",
      "address_1": "7002 S 109th St",
      "city": "La Vista",
      "state": "NE",
      "postal_code": "68128-5729",
      "additional_info_contact": "Maria J. Dosseh\n402-333-1982",
      "reason_for_recall": "Complaints of the 2.0ml tube stopper coming loose during phlebotomy when small diameter tube adapters were not utilized.  Such adapters aid with centering small diameter tubes to properly pierce the middle of the stoppers.",
      "root_cause_description": "Error in labeling",
      "action": "On February 23, 2017,  Streck  electronically notified customers of the updated device correction.  The recalling firm used an electronic mail alert to notify all of their customers the IFU for the recalled product had been revised.  The specified the revision included phlebotomy guidelines specific to the 2.0 ml blood collections tubes.  The revised IFU was provided as a link in the email.  \n\nThe recalling firm is reportedly able to monitor the access of the revised IFU to ensure each customer has received the information.  For further questions, please call (402) 333-1982.",
      "product_quantity": "128,692 tubes",
      "distribution_pattern": "Worldwide Distribution - USA (nationwide) and to the countries of : Belgium, Canada, Germany, Israel, Japan, the Republic of Korea, the Netherlands, and the United Kingdom.  There was no military or government distribution.",
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          "K915213",
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          "K933939",
          "K896514",
          "K882501",
          "K771054"
        ],
        "device_name": "Tubes, Vacuum Sample, With Anticoagulant",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1675",
        "device_class": "2",
        "registration_number": [
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