{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "95089",
      "product_res_number": "Z-0343-2011",
      "event_date_initiated": "2009-12-07",
      "event_date_posted": "2010-11-10",
      "recall_status": "Terminated",
      "event_date_terminated": "2010-11-10",
      "res_event_number": "56976",
      "product_code": "JHX",
      "k_numbers": [
        "K984067"
      ],
      "product_description": "Stratus(R) CS Rotors, catalog number CROTOR, lot number NH42-251-09\nIntended use: Stratus(R) rotors is intended for the separation of whole blood samples for analysis on the Stratus(R) CS analyzer",
      "code_info": "catalog number CROTOR, lot number NH42-251-09",
      "firm_fei_number": "2517506",
      "recalling_firm": "Siemens Healthcare Diagnostics, Inc.",
      "address_1": "500 GBC Drive, Mailstop 514 500 GBC Drive Mailstop 514",
      "address_2": "PO BOX 6101",
      "city": "Newark",
      "state": "DE",
      "postal_code": "19714-6101",
      "additional_info_contact": "Siemens Technical Solutions Center\n302-631-8467",
      "reason_for_recall": "Low frequency defect in the gel filling of this lot that may result in inadequate separation of cells in centrifugation.",
      "root_cause_description": "Process control",
      "action": "The recalling firm, SIEMENS, issued an \"Urgent Field Safety Notice\" dated December 2009 to all affected customers. The notice described the product, problem and the action to be taken by the customers.  The customers were instructed to review the situation with their laboratory director to determine the need to evaluate previously reported test results; immediately examine their CROTOR inventory and discard all bags that are from lot NH42-251-09 including rotors that were not stored in their original packaging (bag); contact Siemens Customer Service Center at 800-241-0420 to request additional no-charge replacements (Note: A \"no-charge\" order has already been placed so that one bag of replacement rotors would be recieved shortly); forward this notice to anyone they may have distributed this product, and  complete and return the FIELD CORRECTION EFFECTIVENESS CHECK via fax at 302-631-8467.\n\nIf you have any questions regarding this information, please contact the Siemens Technical Solution Center at 800-405-6473.",
      "product_quantity": "330 bags",
      "distribution_pattern": "Worldwide distribution: USA including states of AK, AZ, AR, CA, FL, GA, HI, IA, IL, IN, KY, LA, MI, MN, MO, MS, MT, NC, ND, NH, NM, NY, OH, TX, UT, WA, WI,  and WV and country of Canada",
      "openfda": {
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          "K234005",
          "K771324",
          "K973126",
          "K813087",
          "K913380",
          "K790294",
          "K991797",
          "K812759",
          "K873171",
          "K004002",
          "K962549",
          "K791582",
          "K000716",
          "K873399",
          "K030012",
          "K212648",
          "K034055",
          "K120326",
          "K760591",
          "K911121",
          "K051650",
          "K840549",
          "K801728",
          "K881237",
          "K013118",
          "K972782",
          "K081360",
          "K903441"
        ],
        "registration_number": [
          "3002637618",
          "9610987",
          "1036362",
          "2122870",
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          "9680746",
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          "2517506",
          "3003366417",
          "3002806944",
          "3006198300"
        ],
        "fei_number": [
          "1000119795",
          "3002637618",
          "1036362",
          "3002808328",
          "2122870",
          "3014353045",
          "3008344661",
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          "1000206808",
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          "1000136573",
          "2517506",
          "3003366417",
          "3002806944",
          "3006198300"
        ],
        "device_name": "Fluorometric Method, Cpk Or Isoenzymes",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1215",
        "device_class": "2"
      }
    }
  ]
}