{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
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  "results": [
    {
      "status": "Terminated",
      "city": "Spankeren",
      "state": "N/A",
      "country": "Netherlands",
      "classification": "Class III",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "83381",
      "recalling_firm": "ELITech Group B.V.",
      "address_1": "Van Rensselaerweg 4",
      "address_2": "N/A",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide distribution including the state of NY.",
      "recall_number": "Z-2764-2019",
      "product_description": "Viva-ProE  Systems, Model # 6003-670, UDI: 03661540600357 - Product Usage: The ELITech Clinical Systems Selectra ProM is an automated clinical chemistry system intended for use in clinical laboratories. It is intended to be used for a variety of assay methods that have been applied to spectrophotometric and electrochemical techniques. The system has two core modules: one consisting of a spectrophoto-metric system for measurement of analytes using spectrophotometric techniques, such as end point, rate and turbidometric assays. The second module is an electro-meter used for measurement of electrolytes.",
      "product_quantity": "89 units",
      "reason_for_recall": "Software malfunction; The action  being taken due to the device becoming inoperable due to software lockup.",
      "recall_initiation_date": "20160712",
      "center_classification_date": "20190930",
      "termination_date": "20220204",
      "report_date": "20191009",
      "code_info": "1. 14-1301  2. 14-1304  3. 14-1308  4. 14-1314  5. 14-1315  6. 14-1323  7. 14-1324  8. 14-1336  9. 15-1328  10. 15-1332  11. 15-1333  12. 15-1334  13. 15-1335  14. 15-1336  15. 15-1337  16. 15-1338  17. 15-1339  18. 16-1301  19. 16-1302  20. 16-1304  21. 16-1305  22. 16-1312  23. 17-1335"
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