{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "114819",
      "product_res_number": "Z-0637-2013",
      "event_date_initiated": "2012-11-21",
      "event_date_posted": "2013-01-04",
      "recall_status": "Terminated",
      "event_date_terminated": "2014-11-06",
      "res_event_number": "63809",
      "product_code": "JJW",
      "k_numbers": [
        "K943780"
      ],
      "product_description": "Siemens Chek-Stix Combo Pak \nCatalog Number: 1364\n\nChek-Stix Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX positive and negative control strips provide defined results for glucose, bilirubin, ketone (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogin, nitrite, and leukocytes",
      "code_info": "Carton/Bottle Lot Number: C9093061C\t\tP9093061C C9094081J\t\tP9094081J C0100101D\t\tP0100101D C0097091E\t\tP0097091E C9101022E\t\tP9101022E C0099091D\t\tP0099091D C0100101E\t\tP0100101E C9101022H\t\tP9101022H C9101022J\t\tP9101022J C0103042B\t\tP0103042B C0103042G\t\tP0103042G C0106062D\t\tP0106062D C9105052C\t\tP9105052C",
      "firm_fei_number": "3002637618",
      "recalling_firm": "Siemens Healthcare Diagnostics Inc",
      "address_1": "2 Edgewater Dr",
      "city": "Norwood",
      "state": "MA",
      "postal_code": "02062-4637",
      "additional_info_contact": "Mark Smith\n781-269-3158",
      "reason_for_recall": "When these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25C (77F).",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "Siemens issued An Urgent Field Safety Notice  via e-mail to all affected SiemensHealthcare Diagnostics Regional offices on November 21, 2012 both in the United States and foreign accounts. This notice informed customers of the issue with the CLINITEK Atlas and Chek-Stix Positive Urinalysis Control Solutions When these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25C (77F). You can use the reconstituted positive control solution for up to eight hours if the solution is held at 25C (77F) or lower. If the operating temperature is greater than 25C and lower than 30C (77F and 86F), the solution can be used for up to two hours.\nFor questions regarding this recall call 781-269-3158.",
      "product_quantity": "16711",
      "distribution_pattern": "Worldwide Distribution - USA (nationwide) and internationally to Canada,  Aruba, Brazil, Denmark,  India, Mexico, New Zealand, Singapore,Thailand, Bahamas, South Wales, and Hong Kong,",
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          "K780802",
          "K103387",
          "K880495",
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          "K792376",
          "K792374"
        ],
        "registration_number": [
          "2432235",
          "1649661",
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        "fei_number": [
          "2432235",
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          "2016706",
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        ],
        "device_name": "Urinalysis Controls (Assayed And Unassayed)",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1660",
        "device_class": "1"
      }
    }
  ]
}