{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "189570",
      "product_res_number": "Z-0424-2022",
      "event_date_initiated": "2021-09-22",
      "event_date_created": "2021-12-28",
      "recall_status": "Open, Classified",
      "res_event_number": "88797",
      "product_code": "JLS",
      "product_description": "VIDAS PRG Progesterone, REF 30409-01",
      "code_info": "UDI 03573026064952, Lot #s: 1008685490, 1008766980, 1008775630, 1008873180, 1008911240",
      "firm_fei_number": "3002769706",
      "recalling_firm": "bioMerieux, Inc.",
      "address_1": "100 Rodolphe St",
      "city": "Durham",
      "state": "NC",
      "postal_code": "27712-9402",
      "additional_info_contact": "Brian Armstrong\n919-620-2000",
      "reason_for_recall": "bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "For products with No remaining shelf life (taking into account the revised expiration date):\n- Identify impacted lots \n- Stop using the listed impacted lots\n- Destroy the remaining impacted lots in your inventory\n\nFor products with remaining shelf life (taking into account the revised expiration date):\n- Identify impacted products and lots listed\n- Update product expiration date per your internal procedures of the remaining usable lots to meet the new revised expiration date specified in Table 1\n- Continue product use until the revised expiration date.\n\nConsignees are asked to distribute this information to all appropriate personnel in their laboratory, retain a copy in their files, and forward this information to all parties that may use this product, including others to whom you may have transferred affected product.\n\nComplete the Acknowledgement Form in Attachment A and return it to USFieldActions@biomerieux.com or Fax to: (919) 620-3306 to confirm receipt of this notice.",
      "product_quantity": "1818 units",
      "distribution_pattern": "US Nationwide distribution.",
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        "device_name": "Radioimmunoassay, Progesterone",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1620",
        "device_class": "1"
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    }
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}