{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 237 } }, "results": [ { "cfres_id": "130889", "product_res_number": "Z-0170-2015", "event_date_initiated": "2014-10-17", "event_date_posted": "2014-11-07", "recall_status": "Terminated", "event_date_terminated": "2015-06-29", "res_event_number": "69540", "product_code": "LON", "pma_numbers": [ "P870049" ], "product_description": "Rapid Neg BP Combo Panel Type 3; Catalog number B 1017-117.\n\nMicroScan Rapid panels are designed for use in determining identification to the species level and/or antimicrobial agent susceptibility of rapidly growing aerobic and facultatively anaerobic gram negative bacilli.", "code_info": "Catalog number: B1017-117, Siemens Material number 1044632, lot numbers: 2014-12-10, Exp. 2014-12-10; 2015-02-27, Exp 2015-02-27; 2015-06-23, Exp 2015-06-23.", "firm_fei_number": "2919016", "recalling_firm": "Siemens Healthcare Diagnostics, Inc.", "address_1": "2040 Enterprise Blvd", "city": "West Sacramento", "state": "CA", "postal_code": "95691-3427", "additional_info_contact": "Jose Untalan\n916-374-3031", "reason_for_recall": "An increase in false positive susceptible results on Rapid Neg BP Combo Panel Type 3 and Rapid Neg Urine Combo Panel Type 1 used with MicroScan Microbiology Systems.", "root_cause_description": "Nonconforming Material/Component", "action": "Customer Recall notification letters were sent on October 17, 2014. Letters recommend that any remaining inventory be discarded and that consideration be given to reviewing previous test result, conduct patient follow up and/or repeat testing if isolates are still available.\nA second letter clarifying the recall was issued November 7, 2014 which provided additional information as requested by CDRH.", "product_quantity": "1381", "distribution_pattern": "Distributed US (nationwide) including the states of IA, CA, NY, WI, MI, SD, NC, FL, HI, OH, WA, TX, WA, IN, NM, MS, KY, IL, UT, ND, and WY and the country of Canada.", "openfda": { "k_number": [ "K250344", "K020173", "K043389", "K051692", "K020870", "K051689", "K060257", "K201405", "K193299", "K202396", "K024152", "K213899", "K161217", "K163006", "K041982", "K052250", "K031865", "K122359", "K060447", "K082538", "K032399", "K020413", "K023541", "K220546", "K050400", "K050865", "K050780", "K032675", "K061327", "K043237", "K040099", "K222430", "K033907", "K050076", "K061347", "K062938", "K073433", "K063366", "K033557", "K181766", "K020321", "K213931", "K080201", "K121546", "K122547", "K234000", "K172944", "K132674", "K032711", "K063300", "K061673", "K042932", "K060218", "K031589", "K032766", "K080107", "K093224", "K073406", "K020322", "K022045", "K050075", "K050089", "K082852", "K072668", "K073589", "K192110", "K193567", "K063573", "K070809", "K051350", "K051272", "K050002", "K043230", "K083536", "K072695", "K032788", "K091899", "K142170", "K033458", "K162737", "K161510", "K222378", "K214023", "K043458", "K111893", "K183551", "K023361", "K023568", "K121863", "K020142", "K023895", "K201675", "K032314", "K093076", "K232201", "K223478", "K082346", "K083383", "K251579", "K032655", "K030677", "K062687", "K033889", "K031912", "K022129", "K033560", "K050946", "K023634", "K070860", "K181665", "K031679", "K131331", "K020397", "K031601", "K183524", "K213241", "K023527", "K052270", "K063492", "K051266", "K052346", "K091126", "K032275", "K152075", "K031410", "K063597", "K050816", "K062945", "K073083", "K132573", "K123266", "K020185", "K023444", "K082913", "K020168", "K050982", "K032299", "K161437", "K033064", "K113305", "K031984", "K052269", "K022172", "K173523", "K260281", "K131779", "K063301", "K042963", "K140468", "K891577", "K051138", "K051849", "K113783", "K112075", "K020248", "K190905", "K060444", "K063365", "K233986", "K211136", "K061869", "K053097", "K060214", "K220805", "K040716", "K111976", "K200590", "K031306", "K041384", "K052311", "K132909", "K183415", "K212849", "K222073", "K211630", "K063564", "K050555", "K020410", "K032567", "K023858", "K020506", "K063486", "K071317", "K020249", "K023301", "K051183", "K030986", "K161227", "K020319", "K053504", "K030579", "K211748", "K112129", "K210287", "K062207", "K111909", "K103752", "K193572", "K190616", "K023273", "K123404", "K024153", "K020328", "K250447", "K060324", "K020871", "K051311", "K050881", "K063623", "K151320", "K040845", "K031699", "K053186", "K211759", "K020323", "K260282", "K232756", "K183360", "K040106", "K072038", "K031530", "K113200", "K070346", "K020182", "K033362", "K060312", "K061867", "K110106", "K092919", "K141149", "K050747", "K063824", "K030091", "K062206", "K062680", "K021954", "K051204", "K033558", "K060088", "K032153", "K053241", "K050976", "K031943", "K033482", "K062705", "K020398", "K020511", "K223481", "K251713", "K063811", "K052656", "K121100", "K212243", "K050745", "K031602", "K071076", "K230864", "K061355", "K172731", "K132507", "K032738", "K173252", "K060493", "K032861", "K071268", "K163637", "K031429", "K040006", "K163563", "K112000", "K220803", "K042946", "K041572", "K163083", "K234012", "K060558", "K191766", "K060217", "K062944", "K051478", "K020246", "K861958", "K071623", "K032131", "K111599", "K112228", "K020209", "K033784", "K051109" ], "pma_number": [ "N50538", "P840065", "P810024", "N50531", "P800030", "P870049", "N50525", "P800029", "N50487", "N50061", "N50524", "P820073" ], "registration_number": [ "3013718871", "3008007472", "1423662", "3009637528", "3009288740", "1111096", "3027320620", "3031977134", "2022807", "1833407", "3003030793", "1950204", "1119779", "1318354", "3009171251", "3025772277", "3006198300", "3023036790", "3002444944", "3025775667", "2919016", "3007344102", "3007502289" ], "fei_number": [ "3013718871", "3008007472", "3009637528", "3009288740", "1111096", "3027320620", "3006759904", "3031977134", "3000215273", "2022807", "3003030793", "1950204", "1000518597", "1119779", "1318354", "3025772277", "3023036790", "3006198300", "3002444944", "3025775667", "2919016", "3007344102", "3007502289" ], "device_name": "System, Test, Automated, Antimicrobial Susceptibility, Short Incubation", "medical_specialty_description": "Microbiology", "regulation_number": "866.1645", "device_class": "2" } } ] }