{
  "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": "2026-08-22",
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      "address_1": "20 Corporate Pl S",
      "city": "Piscataway",
      "state": "NJ",
      "postal_code": "08854-6144",
      "additional_info_contact": "732-548-5700",
      "reason_for_recall": "An increase in the frequency of non-conformance reports (NCMR) for certain displayed error messages.",
      "root_cause_description": "Device Design",
      "action": "ITC sent  to distributors, self test users and health care professionals on 11/19/07, an Urgent Medical Device Recall Letter requesting return of the devices.",
      "product_quantity": "3,482 units",
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