{ "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": [ { "country": "United States", "city": "Cambridge", "address_1": "150 2nd St", "reason_for_recall": "An incorrect test result for a single analyte may have been reported for up to 800 physician reports", "address_2": "", "product_quantity": "800 reports", "code_info": "Specimen Numbers - QRF038638 QRF039891 QRF041785 QRF045568 QRF045791 QRF046784 QRF046978 QRF047089 QRF048328 QRF048779 QRF049054 QRF049231 QRF049653 QRF049780 QRF049795 QRF050115 QRF050274 QRF050299 QRF050506 QRF051201 QRF051302 QRF051412 QRF051560 QRF051610 QRF051635 QRF051756 QRF051768 QRF051787 QRF051832 QRF051882 QRF051892 QRF051920 QRF051925 QRF051943 QRF051952 QRF051954 QRF051968 QRF051975 QRF051979 QRF051982 QRF051987 QRF052308 QRF052311 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"product_description": "FoundationOne CDx Test Results", "report_date": "20181226", "classification": "Class II", "openfda": {}, "recalling_firm": "Foundation Medicine, Inc.", "recall_number": "Z-0649-2019", "initial_firm_notification": "Letter", "product_type": "Devices", "event_id": "81614", "termination_date": "20200417", "more_code_info": "", "recall_initiation_date": "20181031", "postal_code": "02141-2115", "voluntary_mandated": "Voluntary: Firm initiated", "status": "Terminated" } ] }