{ "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, "total": 1 } }, "results": [ { "status": "Terminated", "city": "Morrisville", "state": "NC", "country": "United States", "classification": "Class II", "openfda": {}, "product_type": "Devices", "event_id": "71352", "recalling_firm": "Tecan US, Inc.", "address_1": "9401 Globe Center Drive", "address_2": "Suite 140", "postal_code": "27560", "voluntary_mandated": "Voluntary: Firm initiated", "initial_firm_notification": "Letter", "distribution_pattern": "US Nationwide Distribution in the states of AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MO, NE NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, including DC", "recall_number": "Z-1970-2015", "product_description": "Infinite 200 PRO in vitro diagnostic. Product Usage: The Tecan Infinite 200 PRO is a multifunctional microplate reader with injector option. The Infinite 200 PRO provides high performance for the vast majority of today\u0019s microplate applications and research and is robotic compatible. The Infinite 200 PRO has been designed as a general purpose laboratory instrument for professional use, supporting common 6 to 384 well microplates conforming to the ANS/SBS standards.", "product_quantity": "868 in total", "reason_for_recall": "A firmware bug causes incorrect values to be displayed for specific measured luminescence values.", "recall_initiation_date": "20150529", "center_classification_date": "20150702", "termination_date": "20170818", "report_date": "20150708", "code_info": "Material Number 30050303. 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