{
  "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": "2026-08-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "114823",
      "product_res_number": "Z-0641-2013",
      "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\r\n(Distributed OUS)\r\nCatalog Number: 1364E\r\n\r\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: C0099091C\t\tP0099091C C0100101F\t\tP0100101F C9101022I\t\t                     P9101022I C0103042D\t\tP0103042D C0106062E\t\tP0106062E",
      "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.\r\nFor questions regarding this recall call 781-269-3158.",
      "product_quantity": "4642",
      "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,",
      "openfda": {
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          "K042446",
          "K792374",
          "K890577",
          "K110846",
          "K781691",
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          "K852295",
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          "K031441",
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          "K842366",
          "K052242",
          "K942853",
          "K832713",
          "K891286",
          "K945913",
          "K934257",
          "K781961",
          "K853603",
          "K890534",
          "K943780",
          "K830834",
          "K880496",
          "K861756",
          "K792376",
          "K843565",
          "K884424",
          "K081908",
          "K810917",
          "K831526",
          "K023928"
        ],
        "registration_number": [
          "2085402",
          "9613959",
          "2531491",
          "2020715",
          "2016706",
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          "3003951180",
          "1832216",
          "2432235",
          "3004493545",
          "3009711478",
          "3010152370",
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        ],
        "fei_number": [
          "3003516723",
          "3002829675",
          "2016706",
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          "3002807423",
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          "1000519735",
          "3010152370",
          "3010421384",
          "3001451797",
          "3000203293"
        ],
        "device_name": "Urinalysis Controls (Assayed And Unassayed)",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1660",
        "device_class": "1"
      }
    }
  ]
}