{
  "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,
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  "results": [
    {
      "cfres_id": "178514",
      "product_res_number": "Z-0812-2020",
      "event_date_initiated": "2019-12-16",
      "event_date_created": "2020-01-16",
      "recall_status": "Terminated",
      "event_date_terminated": "2020-12-11",
      "res_event_number": "84524",
      "product_code": "OHQ",
      "product_description": "Microbiologics QC Sets and Panels, Gram-Positive Blood Culture Control Panel (Inactivated Pellet), Catalog # 8180\nUsed in test systems to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation.",
      "code_info": "Lot # 8180-46 8180-47 8180-48 8180-49 8180-50 8180-51 8180-52",
      "firm_fei_number": "2150138",
      "recalling_firm": "Microbiologics Inc",
      "address_1": "200 Cooper Ave N",
      "city": "Saint Cloud",
      "state": "MN",
      "postal_code": "56303-4440",
      "additional_info_contact": "Technical Support\n320-253-1640",
      "reason_for_recall": "The recommended hydration fluid for the 8180 Gram-Positive Blood Culture Control Panel (Inactivated Pellet), has changed from sterile 0.85% saline or sterile blood culture media to sterile DI water or pH 7.2 phosphate buffer.",
      "root_cause_description": "Device Design",
      "action": "Recall Letters was sent via email to all consignees regarding the correction on 12/16/2019 informing users of a new recommended hydration fluid which is reflected in labeling QC Sets and Panels:  Technical Information TIB.2034 Rev G.\nQuestions can be directed at Technical Support team at 1.320.229.7064 or techsupport@microbiologics.com .  A response form is requested to be returned.",
      "product_quantity": "810",
      "distribution_pattern": "Distributed nationwide including Washington DC, and distributed internationally to Germany and Netherlands.",
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        "device_name": "Multi-Analyte Controls Unassayed",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1660",
        "device_class": "1"
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}