{ "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": [ { "status": "Terminated", "city": "Tarrytown", "state": "NY", "country": "United States", "classification": "Class II", "openfda": {}, "product_type": "Devices", "event_id": "85268", "recalling_firm": "Siemens Healthcare Diagnostics, Inc.", "address_1": "511 Benedict Ave", "address_2": "N/A", "postal_code": "10591-5005", "voluntary_mandated": "Voluntary: Firm initiated", "initial_firm_notification": "Letter", "distribution_pattern": "US Nationwide. Global distribution.", "recall_number": "Z-1797-2020", "product_description": "Atellica CH 930 Analyzer, Siemens Material Number 11067000 with software version v1.21.0 SP1 or lower", "product_quantity": "1807", "reason_for_recall": "Editing an assay Test Definition and switching to another assay s Test Definition screen without saving the changes using the save button on the screen, may corrupt the settings of the assay s test definition, and Auto-Rerun or Auto-Dilution results may generate a result of Zero (0) for quantitative assays or Negative for qualitative assays if a well of the reagent pack is not calibrated.", "recall_initiation_date": "20200227", "center_classification_date": "20200424", "termination_date": "20211025", "report_date": "20200506", "code_info": "UDI: 00630414002163; All systems with software version v1.21.0 SP1 or lower Serial Numbers: CM01702 CM01708 CM00184 CM00196 CM01051 CM01467 CM00770 CM00815 CM00983 CM01053 CM00802 CM01004 CM01903 CM00526 CM00635 CM00809 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CM00728 CM01693 CM01737 CM00513 CM01505 CM01141 CM00353 CM00354" } ] }