{ "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": "2026-09-03", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "cfres_id": "221385", "product_res_number": "Z-2888-2026", "event_date_initiated": "2026-06-26", "event_date_posted": "2026-08-05", "recall_status": "Open, Classified", "res_event_number": "99349", "product_code": "LON", "k_numbers": [ "K201405" ], "product_description": "REF # D23352, MicroScan LabPro V5.03 Panel Update 11 (US), Electronic installed on the following instruments: \n- B1018-280 MicroScan autoSCAN-4 Instrument\n- B1018-283 MicroScan WalkAway-40 plus Instrument\n- B1018-284 MicroScan WalkAway-96 plus Instrument\n- B1018-440 DxM-1040 MicroScan WalkAway Instrument\n- B1018-496 DxM-1096 MicroScan WalkAway Instrument", "code_info": "UDI: 15099590799243/ V5.03 Panel Update 11", "firm_fei_number": "2050012", "recalling_firm": "Beckman Coulter Inc.", "address_1": "250 S Kraemer Blvd", "city": "Brea", "state": "CA", "postal_code": "92821-6232", "additional_info_contact": "Kurtis Montegna\n714-961-5321", "reason_for_recall": "Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications.\"", "root_cause_description": "Software Design Change", "action": "Between the dates of June 26 -29, 2026, Beckman Coulter issued a Urgent Medical Device via Email and US Mail. Beckman Coulter ask consignees to take the following actions: \n\n1. Manually verify results from the panels and assays listed below for Daptomycin or Cefepime when read with the WalkAway instrument or autoSCAN-4 instrument and for Vancomycin when read with the autoSCAN-4 instrument.\n\n2. Continue routine quality control procedures, review flagged or unusual panel results and follow laboratory verification practices prior to reporting results.\n\n3. Beckman Coulter recommends sharing the content of this letter with your laboratory and/or medical director regarding the need to review previous patient test results.\n\n4. Beckman Coulter recommends posting this letter on or near the affected analyzers.", "product_quantity": "158 instruments", "distribution_pattern": "US Nationwide distribution including in the states of AK, AL, AR, CA, CO, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, \tVA, WI, WV, WY.", "openfda": { "k_number": [ "K161510", "K060444", "K073406", "K173523", "K062944", "K202396", "K020168", "K020398", "K022045", "K033458", "K072668", "K062945", "K030986", "K071268", "K073083", "K052311", "K061347", "K031589", "K061355", "K031943", "K051350", "K060217", "K230864", "K063301", "K050089", "K113783", "K121546", "K123266", "K891577", "K060493", "K020248", "K050946", "K063564", "K062705", "K091899", "K060257", "K191766", "K052269", "K041384", "K051689", "K211630", "K042946", "K040845", "K060218", "K050982", "K050075", "K031679", "K022129", "K172944", "K092919", "K192110", "K033784", "K060088", "K024153", "K063824", "K222073", "K032131", "K214023", "K132674", "K161227", "K020319", "K031601", "K031429", "K051183", "K062680", "K211136", "K020870", "K222430", "K063573", "K260282", "K060558", "K071076", "K223478", "K161217", "K060324", "K183551", "K030677", "K050076", "K073433", "K053504", "K220546", "K051266", "K062938", "K023527", "K111909", "K032153", "K051138", "K040716", "K042932", "K063492", "K181766", "K061869", "K043230", "K020185", "K121100", "K020871", "K032314", "K020506", "K080107", "K063365", "K172731", "K151320", "K031912", "K033064", "K111893", "K070346", "K043458", "K161437", "K060214", "K023273", "K210287", "K050555", "K082346", "K113305", "K020246", "K033889", "K061327", "K031984", "K033557", "K201675", "K040099", "K173252", "K083536", "K040006", "K050816", "K062207", "K060312", "K123404", "K193572", "K023444", "K020173", "K080201", "K072695", "K051204", "K062206", "K212243", "K041982", "K111599", "K163006", "K142170", "K021954", "K031699", "K132507", "K063811", "K111976", "K201405", "K050881", "K020511", "K050976", "K033362", "K163563", "K152075", "K211748", "K132909", "K190905", "K051692", "K193299", "K052346", "K071623", "K112000", "K031602", "K121863", "K213931", "K082913", "K052270", "K024152", "K861958", "K233986", "K103752", "K031410", "K112228", "K112075", "K234012", "K032788", "K051311", "K072038", "K082538", "K070809", "K051272", "K051849", "K023858", "K250344", "K260281", "K023568", "K213899", "K031530", "K140468", "K041572", "K082852", "K141149", "K050400", "K093076", "K020397", "K030579", "K050780", "K053186", "K122359", "K183415", "K032399", "K042963", "K033560", "K062687", "K063597", "K051478", "K020323", "K030091", "K163083", "K131779", "K053097", "K020249", "K183360", "K032766", "K061673", "K020413", "K251579", "K183524", "K020321", "K181665", "K071317", "K031306", "K050747", "K083383", "K051109", "K112129", "K220805", "K163637", "K122547", "K193567", "K211759", "K232201", "K032675", "K043237", "K023541", "K033482", "K091126", "K190616", "K043389", "K023301", "K223481", "K020209", "K251713", "K060447", "K113200", "K020322", "K032275", "K023361", "K052656", "K031865", "K022172", "K020328", "K053241", "K162737", "K033907", "K020410", "K220803", "K020182", "K232756", "K050002", "K023634", "K020142", "K050745", "K073589", "K023895", "K222378", "K032861", "K063623", "K032655", "K070860", "K032567", "K063486", "K040106", "K032711", "K050865", "K063300", "K131331", "K093224", "K061867", "K213241", "K250447", "K063366", "K032299", "K234000", "K110106", "K052250", "K032738", "K212849", "K033558", "K200590", "K132573" ], "pma_number": [ "N50487", "N50524", "N50531", "P800030", "P840065", "N50525", "P820073", "P800029", "P870049", "N50538", "P810024", "N50061" ], "registration_number": [ "3013718871", "2022807", "3002444944", "2919016", "1423662", "3023036790", "3006198300", "1950204", "1111096", "3009288740", "3008007472", "3007502289", "3031977134", "3009637528", "1318354", "1119779", "3003030793", "3007344102", "3009171251", "3025772277", "1833407", "3025775667", "3027320620" ], "fei_number": [ "3000215273", "3013718871", "2022807", "3002444944", "2919016", "3023036790", "3006198300", "1950204", "1111096", "3009288740", "3008007472", "3007502289", "3031977134", "3009637528", "1000518597", "1318354", "1119779", "3003030793", "3007344102", "3006759904", "3025772277", "3025775667", "3027320620" ], "device_name": "System, Test, Automated, Antimicrobial Susceptibility, Short Incubation", "medical_specialty_description": "Microbiology", "regulation_number": "866.1645", "device_class": "2" } } ] }