{ "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": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "37195", "product_res_number": "Z-0668-05", "event_date_initiated": "2005-02-07", "event_date_posted": "2005-04-06", "recall_status": "Terminated", "event_date_terminated": "2005-07-05", "res_event_number": "31125", "product_code": "LON", "pma_numbers": [ "P870049" ], "product_description": "MicroScan Rapid Pos Inoculum Broth, Catalog #: B1015-14; Manufactured and distributed by: Dade Behring Inc. 2040 Enterprise Blvd. West Sacramento, CA 95691", "code_info": "Lot Nos.:  050905A-1,\t\t 051005A-1,\t\t 051605A-1,\t\t 051705A-1,\t\t 052305A-1,\t\t 052805B-1", "firm_fei_number": "2919016", "recalling_firm": "Dade Behring", "address_1": "2040 Enterprise Blvd", "city": "West Sacramento", "state": "CA", "postal_code": "95691-3427", "additional_info_contact": "Jose Untalan\n916-374-3285", "reason_for_recall": "There is a potential for reporting of false susceptible anti-microbic results that could result in inappropriate and/or less effective therapy.", "root_cause_description": "Other", "action": "The customer notifications were sent to U.S. customers on January 27, 2005 via FedEx. International customers are to be notified by Dade Behring affiliates in the affected countries by February 10, 2005. Follow up will be made via phone call.", "product_quantity": "324 boxes", "distribution_pattern": "71 consignees including customers in U.S., Puerto Rico and distributors. Number of international customers to be determined at completion of effectiveness check.", "openfda": { "k_number": [ "K053186", "K103752", "K223478", "K093076", "K071268", "K033557", "K053241", "K092919", "K040006", "K063300", "K043230", "K050780", "K020506", "K161217", "K220805", "K230864", "K031601", "K190905", "K232201", "K031943", "K111893", "K043458", "K062938", "K121100", "K861958", "K140468", "K051849", "K051183", "K050816", "K163006", "K020323", "K020249", "K032567", "K063492", "K061867", "K250447", "K122359", "K113783", "K033482", "K082852", "K020871", "K020248", "K070346", "K220803", "K201405", "K060088", "K052250", "K213931", "K020398", "K031912", "K032655", "K071076", "K051138", "K020182", "K050089", "K173523", "K251579", "K113200", "K152075", "K032711", "K060324", "K071623", "K032399", "K161227", "K033558", "K062945", "K051689", "K061347", "K042932", "K063824", "K050946", "K032766", "K041572", "K201675", "K023568", "K050002", "K052311", "K032299", "K023634", "K071317", "K020321", "K211748", "K183551", "K161437", "K062207", "K073433", "K121546", "K131331", "K183415", "K053097", "K020173", "K033362", "K212849", "K041384", "K060558", "K082346", "K222430", "K033907", "K051204", "K063366", "K060217", "K162737", "K063486", "K080107", "K043237", "K060447", "K063564", "K233986", "K020185", "K172731", "K062680", "K061327", "K181766", "K023541", "K891577", "K032153", "K032131", "K020511", "K020410", "K163083", "K063811", "K050745", "K020319", "K032788", "K020397", "K020870", "K040845", "K030986", "K052270", "K032675", "K122547", "K020142", "K250344", "K222073", "K060312", "K123266", "K234012", "K020246", "K032861", "K023301", "K031984", "K070809", "K031602", "K031429", "K050976", "K132507", "K062687", "K031530", "K022172", "K083536", "K024152", "K033458", "K051266", "K083383", "K223481", "K210287", "K052656", "K183524", "K132573", "K063597", "K031699", "K050400", "K032314", "K192110", "K051311", "K072668", "K062206", "K050076", "K110106", "K123404", "K030091", "K032275", "K181665", "K060214", "K053504", "K131779", "K232756", "K082538", "K022129", "K050881", "K080201", "K111976", "K211630", "K111909", "K132674", "K251713", "K051350", "K060218", "K202396", "K063573", "K032738", "K073589", "K060257", "K050555", "K173252", "K200590", "K063365", "K220546", "K093224", "K063623", "K072695", "K213899", "K023361", "K031679", "K040106", "K061673", "K062705", "K141149", "K113305", "K070860", "K193299", "K033560", "K030579", "K051692", "K121863", "K062944", "K112000", "K042963", "K214023", "K024153", "K043389", "K023273", "K021954", "K260282", "K142170", "K091899", "K260281", "K091126", "K031306", "K151320", "K161510", "K041982", "K061869", "K211759", "K023444", "K033064", "K040099", "K072038", "K060444", "K073406", "K033889", "K172944", "K073083", "K183360", "K051478", "K112075", "K050075", "K042946", "K061355", "K060493", "K031410", "K052346", "K023527", "K050982", "K023895", "K020328", "K191766", "K051272", "K112228", "K050865", "K020413", "K052269", "K020322", "K111599", "K132909", "K163637", "K222378", "K163563", "K020209", "K020168", "K212243", "K234000", "K030677", "K213241", "K112129", "K193567", "K040716", "K031589", "K082913", "K190616", "K023858", "K031865", "K193572", "K022045", "K050747", "K211136", "K051109", "K063301", "K033784" ], "pma_number": [ "N50061", "P810024", "N50524", "P870049", "N50531", "P820073", "P840065", "P800030", "N50525", "N50487", "P800029", "N50538" ], "registration_number": [ "3009288740", "2919016", "3008007472", "3027320620", "3013718871", "3006198300", "2022807", "3031977134", "1833407", "3003030793", "3025772277", "3009637528", "3009171251", "1950204", "3025775667", "1318354", "1119779", "1111096", "3002444944", "3007502289", "3007344102", "3023036790", "1423662" ], "fei_number": [ "3009288740", "2919016", "3008007472", "3027320620", "3013718871", "3006198300", "2022807", "3031977134", "3003030793", "3000215273", "3025772277", "3009637528", "1950204", "3025775667", "1318354", "1119779", "1111096", "1000518597", "3002444944", "3007502289", "3007344102", "3023036790", "3006759904" ], "device_name": "System, Test, Automated, Antimicrobial Susceptibility, Short Incubation", "medical_specialty_description": "Microbiology", "regulation_number": "866.1645", "device_class": "2" } } ] }