{
  "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,
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  "results": [
    {
      "cfres_id": "85853",
      "product_res_number": "Z-0818-2010",
      "event_date_initiated": "2009-07-20",
      "event_date_posted": "2010-02-23",
      "recall_status": "Terminated",
      "event_date_terminated": "2012-04-25",
      "res_event_number": "53553",
      "product_code": "JWX",
      "product_description": "Staphytect Plus, packaged in 100- and 500-test boxes, Catalog #DR0850M (100 tests) and #DR0850B (500 tests).  Oxoid Ltd., Wade Road, Basingstoke, Hants UK.\n\nLatex slide agglutination test for the differentiation of staphylococcus aureus by detection of clumping factor, Protein A and certain polysaccarides found in methicillin-resistant S. aureus (MRSA) from those staphylococci that do not possess these properties.",
      "code_info": "100-test boxes - Lot Numbers: J539110, Exp. Nov 2009, and J591710, Exp. Jan 2010;  500-test boxes - Lot Numbers: J577920, Exp. Jan 2010; and J610620, Exp. May 2010",
      "firm_fei_number": "1924669",
      "recalling_firm": "Remel, Inc",
      "address_1": "12076 Santa Fe Trail Dr",
      "city": "Lenexa",
      "state": "KS",
      "postal_code": "66215-3519",
      "additional_info_contact": "Debbie Wyatt\n913-895-4075",
      "reason_for_recall": "The products may give false positive results with some non-Staphylococcus aureus strains",
      "root_cause_description": "Process control",
      "action": "Thermo Fischer Scientific, Remel Inc. issued letters dated July 20, 2009 via regular mail explaining the reason for recall, risks involved, and requested they discard all remaining product.  A Product Inventory Checklist was enclosed to report the amount of product their customer discarded.  A second letter dated October 19, 2009 was issued via certified mail.\n\nFor further information, contact Thermo Fischer Scientific, Remel Inc. at 1-800-255-6730, Extension 3304185.",
      "product_quantity": "50 boxes (47 DR0850M; 3 DR0850B)",
      "distribution_pattern": "Nationwide Distribution -- MN, CT, FL, GA, CA, NY, MI, MO, PA, and IL.",
      "openfda": {
        "k_number": [
          "K854278",
          "K972030",
          "K821962",
          "K855220",
          "K905617",
          "K831918",
          "K923212",
          "K813614",
          "K830783",
          "K822558",
          "K811098",
          "K090964",
          "K843560",
          "K902259",
          "K926173",
          "K822144",
          "K964315",
          "K852997",
          "K874019",
          "K945538"
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          "3009307598",
          "8010096",
          "9615754",
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          "1924669"
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          "3007808629",
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          "1924669",
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          "1641328",
          "1000306617"
        ],
        "device_name": "Kit, Screening, Staphylococcus Aureus",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.2660",
        "device_class": "1"
      }
    }
  ]
}