{
  "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": "Terminated",
      "city": "Singapore",
      "state": "",
      "country": "Singapore",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "83786",
      "recalling_firm": "Life Technologies Holdings Pte Ltd",
      "address_1": "Blk 33 Marsiling Ind Estate Road 3",
      "address_2": "#07-06",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "states : AZ, CA, CO, CT, FL, GA, IN, MA, MD, NC, NJ, NM, NY, OR, TX, VA, WA    OUS: South Korea, ITALY, China, Japan, Singapore, Germany, TAIWAN, Poland",
      "recall_number": "Z-0187-2020",
      "product_description": "Torrent Suite Dx Software Version 5.6.4  Catalog Number:A33178  OEM Customer software: Sentosa SQ Suite Software v5.6.20  UDI: (01)10190302005654 (11)000000 (10)5.6.4 (240)A33178",
      "product_quantity": "total of Ion+vela +chassis =400 units",
      "reason_for_recall": "Torrent SuiteTM Dx analysis software, a component of the Ion PGM Dx Instrument System, incorrectly displays a positive result when a different analytical or de novo variant is detected at the same locus as a specified clinical variant",
      "recall_initiation_date": "20190926",
      "center_classification_date": "20191023",
      "termination_date": "20211123",
      "report_date": "20191030",
      "code_info": "The field action is associated with the software available on the PGM Dx instrument, therefore no lot code is applicable for this part type",
      "more_code_info": ""
    }
  ]
}