{ "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": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "cfres_id": "192648", "product_res_number": "Z-0981-2022", "event_date_initiated": "2022-02-18", "event_date_created": "2022-04-21", "recall_status": "Open, Classified", "res_event_number": "89831", "product_code": "OYJ", "k_numbers": [ "K152464" ], "product_description": "ORAcollect Dx, Catalog Number/SKU: OCD-100, OCD-100A. 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The shelf-life \"Collect sample by/Use by\" date found on the collection device tube label has been reduced by 12 months. Contact firm if unable to recover the minimum input volume required for sample extraction. Submit online acknowledgement form and contact your DNA Genotek Account manager or Technical Services with questions: support@dnagenotek.com.", "product_quantity": "2,375,514 (US: 2,148,222 OUS: 227,292)", "distribution_pattern": "Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NV, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, WI and the countries of Australia Belgium, Brazil, Canada, Chile, China, Croatia Denmark, Finland, Germany, Great Britain, Italy, Japan, Netherlands, South Africa, and Thailand.", "openfda": { "k_number": [ "K192947", "K141410", "K152556", "K110701", "K152464", "K212745", "K192920" ], "registration_number": [ "3006413195", "3007699459", "3005406097", "3011854984", "3011845225", "3001452053", "3011057574", "3042854290", "3015209536", "3009746061", "8022032", "3022474803", "3004142665", "3013248161", "3004597845", "3003742580" ], "fei_number": [ "3006413195", "3007699459", "3001717360", "3005406097", "3011854984", "3011845225", "3001452053", "3011057574", "3042854290", "3015209536", "3009746061", "3022474803", "3004142665", "3013248161", "3004597845", "3003742580" ], "device_name": "Dna Specimen Collection, Saliva", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.1675", "device_class": "2" } } ] }