{
  "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": "216528",
      "product_res_number": "Z-0534-2026",
      "event_date_initiated": "2025-10-01",
      "event_date_posted": "2025-11-17",
      "recall_status": "Open, Classified",
      "res_event_number": "97763",
      "product_code": "LJB",
      "product_description": "Brand Name: ReQuest Measles IgG\nProduct Name: Rubeola IgG Enzyme Linked Immunoabsorbant Assay\nModel/Catalog Number: 01-190\nSoftware Version: N/A\nProduct Description: Measles IgG tests, performed using ELISA (Enzyme-Linked Immunosorbent Assay) method, used to detect the presence of IgG antibodies against measles virus in a patient's serum or plasma\nComponent: not a component",
      "code_info": "Lot Code: DI# 00850487007357 \nLots affected: L07024 and E03025",
      "firm_fei_number": "3000206132",
      "recalling_firm": "Quest International, Inc.",
      "address_1": "8127 Nw 29th St",
      "city": "Doral",
      "state": "FL",
      "postal_code": "33122-1051",
      "additional_info_contact": "Steve Andrus\n+1-772-2836540",
      "reason_for_recall": "Due to distributing the measles IgG IVD without a premarket approved/cleared.",
      "root_cause_description": "No Marketing Application",
      "action": "On 10/01/2025, the firm email an \"URGENT: Medical Device Recall Measles IgG IFU\" letter to customers informing them that the Measles IgG Medical Device is subject to the limitations of exemption from premarket notification (510(k)) under 21 CFR866.9(c)(7) and is subject to the 510(k) premarket requirements prior to being marketed and distributed in the U.S.\n\nCustomers are instructed to examine their inventory, discontinue use and quarantine the affected lot and review the updated Instruction for Use (IFU) and ensure all relevant personnel are informed of the changes.  The previous version of the IFU should be replace with the updated version, Revision 9.\n\nThe updated IFU (Revision 9) can also be requested by contacting Customer Support team at jopain@awartech.com.\n\nAwareness Technology, Inc. will be revising the intended use of the product to be only for qualitative detection of human IgG antibodies to measles virus in human serum by enzyme immunoassay.  The company will also be removing language in the Instructions for Use (IFU) that could be interpreted as determining immune status, statements regarding paired sera for demonstrating seroconversion or significant rise in antibody levels, and any reference to semi-quantitative procedures.\n\nThe updated IFU (Revision 9) will be included in all product shipments starting 10/01/2025.\n\nFor questions or assistance, contact Customer Service at jcopain@awaretech.com.",
      "distribution_pattern": "All products were distributed in the United States.  (Utah, Washington).",
      "openfda": {
        "k_number": [
          "K910290",
          "K821762",
          "K873925",
          "K903961",
          "K922335",
          "K974552",
          "K971620",
          "K904854",
          "K891990",
          "K904083",
          "K922330"
        ],
        "registration_number": [
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          "1641328",
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        "fei_number": [
          "2245285",
          "1641328",
          "3005542422",
          "1318354",
          "3013718871",
          "2915274",
          "2242436",
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          "3002346973",
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          "3002808212",
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          "3003268355",
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        ],
        "device_name": "Enzyme Linked Immunoabsorbent Assay, Rubeola Igg",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.3520",
        "device_class": "1"
      }
    }
  ]
}