{
  "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": "100141",
      "product_res_number": "Z-0837-2012",
      "event_date_initiated": "2010-09-28",
      "event_date_posted": "2012-01-23",
      "recall_status": "Terminated",
      "event_date_terminated": "2012-05-31",
      "res_event_number": "58551",
      "product_code": "LKQ",
      "k_numbers": [
        "K982485"
      ],
      "product_description": "SeraQuest***CMV IgM TEST SET For the detection of CMV IgM Antibodies 96 Test Set Cat. No. 01-150 Store 2-8 C  For In Vitro Diagnostic Use***Contents: 1 96 wells bag with holder, 1 Negative Control*, 1 Positive Control*, 1 Substrate, 1 Stop Solution, 1 Conjugate*, 1 Calibrator 1*, 1 Calibrator 2*, 1 Diluent for Specimen*, 1 Wash Concentrate*, *Contains Sodium Azide Lot No. E1700 Doral, FL 33122 USA Exp. Date: May 11.\r\n\r\n\r\n\r\n\r\nBIORAD***CMV IgM EIA For the detection of CMV IgM Antibodies Xn-HARMFUL Cat. No. 25178 96 Test Set Store 2-8 C ID: grey For In Vitro Diagnostic Use*** Contents: I CMV IgM Microplate (96 wells), 1 Negative Control* (0.6 mL), 1 Positive Control (0.6 mL), 1 Substrate (12 mL), 1 Stop Reagent (12 mL), 2 Conjugate* (12 mL), 1 Calibrator 1* (0.6 mL), 1 Calibrator 2* (0.6 mL) , 1 Diluent* (25 mL), 1 Wash Concentrate* (30 mL), *0.1% Sodium Azide Lot No. E1700 Distributed by: Bio-Rad Laboratories-Redmond, WA 98052.",
      "code_info": "Lot Number: E1700",
      "firm_fei_number": "3000206132",
      "recalling_firm": "Quest International, Inc.",
      "address_1": "8127 NW 29th St",
      "city": "Doral",
      "state": "FL",
      "postal_code": "33122",
      "additional_info_contact": "Oscar R. Compain\n305-948-8788",
      "reason_for_recall": "Quest International recalled their CMV IgM Test kit because the device failed the test run due to lack of activity in the coated wells.",
      "root_cause_description": "Storage",
      "action": "On September 28, 2010, Quest International, Inc. issued a Memo to its Customers who received the CMV IgM Lot E1700.  The memo identified the affected product and stated the problem with the device.  The memo asked customers to let the firm know if they had any remaining inventory from the affected lot and the product would be replaced immediately.  Questions should be directed to 305-592-6991.",
      "product_quantity": "315",
      "distribution_pattern": "Nationwide Distribution -- Washington and California.",
      "openfda": {
        "k_number": [
          "K972884",
          "K860450",
          "K893466",
          "K853889",
          "K872942",
          "K863798",
          "K913080",
          "K871832",
          "K900743",
          "K914789",
          "K922580",
          "K893465",
          "K872881",
          "K831711",
          "K933549",
          "K861363",
          "K100433",
          "K854839"
        ],
        "device_name": "Antibody Igm,If, Cytomegalovirus Virus",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.3175",
        "device_class": "2",
        "registration_number": [
          "1219913",
          "3032705",
          "3007088335",
          "3002806944",
          "2915274",
          "3005360469",
          "2242436",
          "8020790",
          "2029372",
          "2432235"
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        "fei_number": [
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          "3002701146",
          "3002806944",
          "1220394",
          "2915274",
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          "3005670738",
          "1000611339",
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}