{
  "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": "2026-09-28",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "205457",
      "product_res_number": "Z-1075-2024",
      "event_date_initiated": "2024-01-08",
      "event_date_posted": "2024-02-12",
      "recall_status": "Open, Classified",
      "res_event_number": "93801",
      "product_code": "OHQ",
      "product_description": "Microbiologics Enteric Pathogens Control Panel (Inactivated Pellet), REF 8184.",
      "code_info": "Lot #8184-68, Exp. 5/31/2025, UDI-DI 70845357041448.\n\nUPDATE:  The recall was expanded on 1/23/2024 to include the following additional lot numbers:\n\n8184-65, exp. 3/31/2025; 8184-66, exp. 4/30/2025; 8184-67, exp. 5/31/2025; 8184-69, exp. 6/30/2025; 8184-70, exp. 8/31/2025; and 8184-71, exp. 8/31/2025.",
      "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": "Rebecca Neu\n320-229-7080",
      "reason_for_recall": "The negative control was contaminated with one of the positive control pathogens (Norovirus).  This would result in users getting a positive call for Norovirus when running the negative control.",
      "root_cause_description": "Process control",
      "action": "The recalling firm issued letters dated 1/8/2024 beginning 1/8/2024 informing the consignee of the issue and providing the following instructions: (1) Review lab procedures to understand how this information affects your usage; (2) Use or discard depending on your lab procedures and how this information affects your usage; (3) Complete the response form provided; (4) Return the response form to the firm; (5) keep the letter for your records; and (6) contact Microbiologics if a replacement kit is needed.\n\nOn 1/25/2024, the firm issued letters dated 1/24/2024 via email to notify consignees they have expanded the recall to include additional lot numbers.  Other than providing additional lot numbers, the letter was the same as the initial letter issued on 1/8/2024.  The firm reported the email that had the letter attached alerted the consignee that the recall was expanded to include additional lot numbers.",
      "product_quantity": "580 packages",
      "distribution_pattern": "US Nationwide distribution in the states of AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, MA, MI, MN, MO, MS, MT, NE, NH, NJ, NY, OH, PA, RI, TN, TX, VA, WA, WI, WV, and WY.  There was government distribution and no military distribution.\n\nForeign distribution was made to France.",
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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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    }
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