{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "72795", "product_res_number": "Z-0540-2009", "event_date_initiated": "2008-07-31", "event_date_posted": "2009-02-04", "recall_status": "Terminated", "event_date_terminated": "2010-11-29", "res_event_number": "49114", "product_code": "LON", "k_numbers": [ "K020246" ], "product_description": "MicroScan Synergies Plus Dried Overnight Gram Negative MIC/Combo Panels, 20 panels per box. Medical device designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification to the species level of colonies, grown on solid media, of rapidly growing aerobic and facultative anaerobic gram-negative bacteria.\n\nCatalog numbers B1016-100, B1016-101, B1016-102, B1016-105, B1016-107, B1016-108, B1016-109, B1016-119, B1016-120, B1016-121, B1016-122, B1016-126, B1016-127, B1016-128, B1016-129, B1016-131, B1016-132, B1016-61a, B1016-62a, B1016-64a, B1016-65a, B1016-80, B1016-82, B1017-300, B1017-301, B1017-302, B1017-303, B1017-304, B1017-305, B1017-306, B1017-307, B1017-308, B1017-309, B1017-312, B1017-313, B1017-315, B1017-400, B1017-401, B1017-402, B1017-403, B1017-404, B1017-405, B1017-406, B1017-407, J1016-311c, J1016-312c, J1016-611c, J1016-611j, J1016-612b, J1016-612J, J1016-632J, J1016-623m, J1016-631J, J1016-632J, J1016-65c, J1016-66J, J1025-311, J1025-312, J1025-333, and J1025-611", "code_info": "All lots", "firm_fei_number": "2919016", "recalling_firm": "Siemens Microscan", "address_1": "1584 Enterprise Blvd", "city": "West Sacramento", "state": "CA", "postal_code": "95691-3422", "additional_info_contact": "Leslie Ardizone \n916-374-3075", "reason_for_recall": "Falsely lowered imipenem MICs may result, leading to major errors in results.", "root_cause_description": "Other", "action": "Consignees were notified on July 31, 2008 by letter (Urgent Device Correction) sent via FedEx overnight. International consignees were notified by Siemens Healthcare Diagnostics associates in affected countries. The letter described the problem and provided users with safety instructions to follow until an update is provided. Contact Siemens Healthcare Diagnostics Inc. at 916-374-3075 for additional assistance.", "product_quantity": "Total of both Negative and Synergy: 569,375 boxes", "distribution_pattern": "Worldwide", "openfda": { "k_number": [ "K030091", "K031984", "K050747", "K050075", "K061327", "K220805", "K023634", "K063301", "K132909", "K020185", "K032275", "K033889", "K023858", "K111976", "K020870", "K051692", "K063564", "K122547", "K053504", "K223478", "K024152", "K251713", "K050780", "K121100", "K031429", "K202396", "K072695", "K071268", "K023444", "K063811", "K220803", "K050400", "K063573", "K113783", "K020328", "K110106", "K020319", "K112000", "K141149", "K234012", "K083383", "K051138", "K122359", "K062944", "K121863", "K030677", "K113200", "K260282", "K021954", "K043458", "K061867", "K093076", "K161227", "K032655", "K033907", "K032766", "K070346", "K070809", "K063366", "K051272", "K031601", "K060214", "K214023", "K062945", "K033064", "K050982", "K050555", "K232756", "K061869", "K192110", "K172944", "K031865", "K080201", "K020322", "K063486", "K063824", "K113305", "K181665", "K073406", "K042946", "K061347", "K121546", "K052346", "K173252", "K033784", "K020323", "K233986", "K052656", "K052270", "K020511", "K052311", "K043237", "K062705", "K023361", "K083536", "K222430", "K091899", "K152075", "K032567", "K061673", "K211630", "K161217", "K062207", "K020173", "K082852", "K092919", "K063623", "K051478", "K040845", "K051311", "K033560", "K073083", "K212849", "K112129", "K232201", "K023527", "K051689", "K163006", "K020182", "K023568", "K172731", "K041384", "K082346", "K020397", "K040106", "K861958", "K260281", "K183551", "K211759", "K022129", "K033557", "K072668", "K020142", "K051266", "K060257", "K193299", "K031943", "K050816", "K201675", "K191766", "K230864", "K072038", "K024153", "K023895", "K193572", "K132674", "K111893", "K040006", "K032399", "K053241", "K063492", "K032675", "K041982", "K023301", "K123404", "K050089", "K250344", "K162737", "K211136", "K031589", "K060088", "K071623", "K163083", "K022045", "K052250", "K031679", "K023273", "K031699", "K073433", "K031912", "K063597", "K043230", "K161510", "K060444", "K020249", "K091126", "K070860", "K051204", "K050865", "K040099", "K042932", "K052269", "K111599", "K060312", "K222073", "K051350", "K073589", "K131331", "K213241", "K023541", "K071317", "K032711", "K033458", "K032861", "K032788", "K032153", "K071076", "K032314", "K020248", "K193567", "K132573", "K142170", "K020246", "K062687", "K112228", "K042963", "K020871", "K062206", "K033362", "K030986", "K051849", "K063365", "K163563", "K020398", "K082913", "K053097", "K050976", "K020413", "K223481", "K183524", "K050076", "K051109", "K063300", "K151320", "K050881", "K082538", "K080107", "K212243", "K051183", "K022172", "K251579", "K050002", "K032131", "K060447", "K033482", "K041572", "K181766", "K061355", "K062938", "K033558", "K190905", "K211748", "K032738", "K213899", "K112075", "K050946", "K111909", "K140468", "K060324", "K053186", "K103752", "K060493", "K234000", "K060218", "K031306", "K891577", "K050745", "K163637", "K190616", "K222378", "K220546", "K031530", "K173523", "K020168", "K131779", "K060558", "K161437", "K210287", "K030579", "K031602", "K020209", "K250447", "K213931", "K201405", "K040716", "K020321", "K183415", "K020410", "K060217", "K032299", "K062680", "K132507", "K123266", "K093224", "K020506", "K043389", "K200590", "K031410", "K183360" ], "pma_number": [ "N50487", "P800029", "N50061", "N50524", "P840065", "P810024", "N50525", "N50538", "P820073", "P800030", "N50531", "P870049" ], "registration_number": [ "3009288740", "1318354", "3013718871", "3025775667", "3025772277", "1111096", "3006198300", "3009637528", "3002444944", "2919016", "1423662", "3031977134", "3007502289", "3009171251", "1119779", "3023036790", "3008007472", "2022807", "1833407", "1950204", "3007344102", "3027320620", "3003030793" ], "fei_number": [ "1000518597", "3009288740", "1318354", "3013718871", "3025775667", "3025772277", "1111096", "3006198300", "3009637528", "3006759904", "3002444944", "2919016", "3031977134", "3007502289", "1119779", "3023036790", "3008007472", "2022807", "3000215273", "1950204", "3007344102", "3027320620", "3003030793" ], "device_name": "System, Test, Automated, Antimicrobial Susceptibility, Short Incubation", "medical_specialty_description": "Microbiology", "regulation_number": "866.1645", "device_class": "2" } } ] }