{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Austin",
      "state": "TX",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "83470",
      "recalling_firm": "Luminex Corporation",
      "address_1": "12212 Technology Blvd",
      "address_2": "N/A",
      "postal_code": "78727-6101",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "US: AK, AL, AZ,CA,CO,FL,GA,IL,KS,KY,LA,MA,MD,ME,MI,MN,MO,MS,MT,NC,NE,NJ,NM,NY,OH,ON,OR,PA,TN,TX,UT,VA,VT,WA,WI,    OUS: Belgium, Canada, Thailand, Germany, Singapore, United Kingdom",
      "recall_number": "Z-2287-2019",
      "product_description": "ARIES C. difficile Assay , REF 50-10018, UDI # 00840487100059",
      "product_quantity": "N/A",
      "reason_for_recall": "Through internal investigation, it was discovered that  a portion  of side cassette assemblies (SCAs) back side seal (BSS) did not meet design specification, resulting in partially sealed SCAs. The impact of a partial seal of the BSS could result in potential decrease of volume for each solution in the SCAs and decreased sensitivity or stability of the assay.",
      "recall_initiation_date": "20190220",
      "center_classification_date": "20190815",
      "report_date": "20190821",
      "code_info": "Lot numbers & discontinue use by dates for Part Number 50-10018  AA7306 - Immediately;  AA7311 - 2/27/2019;  AA7627 - 3/28/2019;  AA7634 - 4/3/2019"
    }
  ]
}