{ "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": "San Jose", "state": "CA", "country": "United States", "classification": "Class III", "openfda": {}, "product_type": "Devices", "event_id": "71502", "recalling_firm": "BD Biosciences, Systems & Reagents", "address_1": "2350 Qume Dr", "address_2": "N/A", "postal_code": "95131-1812", "voluntary_mandated": "Voluntary: Firm initiated", "initial_firm_notification": "Letter", "distribution_pattern": "Nationwide Distribution", "recall_number": "Z-2090-2015", "product_description": "BD Flow Cytometers; used on all BD FACSCount, BD FACSCalibur, BD FACSCanto, BD FACSCanto II, BD LSR II, BD LSRFortessa,BD FACSAria, BD FACSAria II, BD FACSAria Ill, BD lnflux, BD FACSArray,BD Pathway 855, BD Pathway 435 and all SORP instruments. BD Biosciences Flow cytometers for the enumeration of tissue and biological fluid samples such as blood and blood components.", "product_quantity": "2188 units", "reason_for_recall": "Instruments installed between June 2007 and September 2011 do not contain labeling pursuant to the Food and Drug Administration's (FDA's) Guidance on Laser Products- Conformance with IEC 60825-1 and IEC 60601-2-22 (Laser Notice No. 50).", "recall_initiation_date": "20150615", "center_classification_date": "20150716", "termination_date": "20160812", "report_date": "20150722", "code_info": "Material No. Serial No. 343202 E0565, 343202 E3190, 338960 V96100212, 338962 V96300187, 338962 V96300189, 342975 E97500564, 338962 V96300231, 342975 E97500700, 33300472 H47200110, 338962 V96300567, 338960 V96100817, 338960 V96100911, 338960 V96100913, 338962 V96300761, 338960 V96101255, 648063 H06300007, 647793 H79300005, 343276 E4731, 337175 V07300249, 647785 H64778500001, 647793 H64779300011, 338960 V33896101603, 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