{
  "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,
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  "results": [
    {
      "cfres_id": "66394",
      "product_res_number": "Z-0722-2008",
      "event_date_initiated": "2007-10-15",
      "event_date_posted": "2008-02-15",
      "recall_status": "Terminated",
      "event_date_terminated": "2011-04-07",
      "res_event_number": "45530",
      "product_code": "JTR",
      "product_description": "PML -- Vitek NH ID Card (NHI) Set -  Quality Control kit for culture media.  Each kit includes a 5 pack of LyfoCults Haemophilus parainfluenzae - Lot # 185-1 Exp 13AUG2008.  PML Micrcobiologicals, 27120 SW 95th Avenue, Wilsonville, Oregon 97070",
      "code_info": "Lot # 185-1, Catalog # 201130 - Vitek NH ID Card (HHI) Set; Lot # 233851-1, Catalog # 101364 - LyfoCults Microorganism",
      "firm_fei_number": "3017344",
      "recalling_firm": "PML, Inc. dba Pml Microbiologicals Inc.",
      "address_1": "27120 Sw 95th Ave",
      "address_2": "P.o. Box 570",
      "city": "Wilsonville",
      "state": "OR",
      "postal_code": "97070-0570",
      "additional_info_contact": "Jeffrey A. Miller\n503-570-2517",
      "reason_for_recall": "Incorrect micro-organism-- .Quality control In-vitro diagnostic test was manufactured with Cryptococcus neoformans (ATCC 76484) instead of Haemophilus parainfluenzae (ATCC 7901).",
      "root_cause_description": "Mixed-up of materials/components",
      "action": "On 10/15/2007, firm notified consignees by telephone.  A follow up letter dated 10/26/07, was faxed  to customers instructing them to discontinue use and discard remaining inventory on site as a biohazardous material.  Consignees were requested to fax back response indicating the amount  of product they had on hand at time of notification.",
      "product_quantity": "1 kit.  Kit contains 1 pack (each pack contains 5 vials of Haemophilus parainfluenzae)",
      "distribution_pattern": "Nationwide Distribution",
      "openfda": {
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          "K821660",
          "K855198",
          "K820064",
          "K842129",
          "K862914",
          "K812698",
          "K861022",
          "K831653",
          "K822954",
          "K830133",
          "K871121"
        ],
        "device_name": "Kit, Quality Control For Culture Media",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.2480",
        "device_class": "1",
        "registration_number": [
          "2518630",
          "2150138",
          "1050138",
          "2436875",
          "1924669",
          "3006091463",
          "2030538",
          "9610649",
          "3015715780"
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          "2518630",
          "2150138",
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}