{ "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": "204312", "product_res_number": "Z-0560-2024", "event_date_initiated": "2023-11-03", "event_date_posted": "2023-12-15", "recall_status": "Open, Classified", "res_event_number": "93423", "product_code": "CEM", "k_numbers": [ "K121012" ], "product_description": "Roche Cobas 8000 and Cobas PRO Interface Module (CO8 IM)- IVD FlexLab Automation System -a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory.\n\nHardware versions: FLX-247-00\nFirmware versions: COBASa_2.2.0, COBASa_2.3.0", "code_info": "FlexLab UDI-DI:07640172340004\nHardware versions: FLX-247-00\nFirmware versions: COBASa_2.2.0, COBASa_2.3.0\nSerial Number US: \nFLX.0208\n\nSerial Numbers OUS:\nSerial Number\nFLX.0116\nFLX.0165\nFLX.0178\nFLX.067\nFLX.0127\nFLX.0128\nFLX.0150\nFLX.0154\nFLX.012\nFLX.0121\nFLX.0132\nFLX.031\nFLX.048\nFLX.049", "firm_fei_number": "3010825766", "recalling_firm": "Inpeco S.A.", "address_1": "Via San Gottardo 10 10 via san gottardo", "city": "Lugano", "country": "Switzerland", "reason_for_recall": "Firmware of the Interface Module with Roche Cobas 8000 and Cobas PRO (CO8 IM) may lead to a delayed sample tube processing.", "root_cause_description": "Software Design Change", "action": "Inpeco issued Urgent Medical Device Correction Letter (Recall-identifier: 3010825766 11/06/23 002 C) via email on 11/3/23. Letter states reason for recall, health risk and action to take:\nPlease apply the following instructions to detect the sample tubes potentially impacted by the issue (Step 1) and to manage them according to the specific occurred scenario (Step 2). If Step 1 leads to determine that the issue has not occurred, Step 2 is not to be performed.\nNote: The test orders status displayed on the IUI is not overwritten neither changed in any way due to the issue: it would be possible to monitor the turn-around time of sample tubes processed by the CO8 IM in order to identify any overdue sample tube with tests still to be executed.\nContact your local technical support provider if you need assistance in implementing these actions. Your service provider will contact you to schedule the firmware upgrade.\nUntil the service visit please maintain awareness on this notice and apply the actions\nrecommended above.\nTransmission of this Recall Letter:\nPlease transfer this notice to whom it might concern.\nPlease complete and return the Customer Letter Receipt Confirmation and Implementation Check form attached to this letter within 30 days directly to the email address specified in the email communication.\nContact reference person:\nFor any clarification you may need, do not hesitate to contact:\nEva Balzarotti - Regulatory Affairs Manager\nE-mail: regulatory.affairs@inpeco.com\nPhone: (+41) 91 9118 224", "product_quantity": "1 unit US: 14 units OUS", "distribution_pattern": "Worldwide - US Nationwide distribution in the state of MA and the countries of AUSTRIA, BELGIUM, DENMARK, ITALY, NORWAY, SPAIN.", "openfda": { "k_number": [ "K832036", "K843454", "K112995", "K060373", "K073157", "K843008", "K833696", "K112788", "K121040", "K915345", "K851100", "K042291", "K112408", "K253491", "K200544", "K771837", "K844955", "K840887", "K915177", "K883240", "K230890", "K052914", "K961115", "K932044", "K854723", "K791175", "K901041", "K040750", "K923038", "K870033", "K800016", "K900788", "K061730", "K241037", "K912649", "K042270", "K884769", "K897110", "K922943", "K853068", "K844806", "K961326", "K993083", "K800054", "K842315", "K841575", "K853531", "K870657", "K092686", "K895664", "K901039", "K843239", "K092849", "K833159", "K851808", "K970330", "K061107", "K896692", "K032311", "K830104", "K013373", "K821822", "K850950", "K220396", "K802158", "K822441", "K854298", "K010061", "K900300", "K884566", "K811310", "K791692", "K842786", "K851350", "K083680", "K844044", "K915178", "K771118", "K121012", "K974784", "K890792", "K093318", "K853356", "K833776", "K110520", "K800692", "K840961", "K790018", "K112412" ], "device_name": "Electrode, Ion Specific, Potassium", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.1600", "device_class": "2", "registration_number": [ "", "9610633", "8030478", "3008244372", "3004378326", "1036362", "2939693", "9610126", "1827821", "3000308930", "1220649", "1000414342", "3002637618", "1181121", "3023268435", "2517506", "9614673", "3003795116", "3005643513", "1319809", "1036223", "9610529", "1219913", "3003593973", "1317202", "1219029", "2030861", "1717966", "8020888", "2245578", "3007662974", "1000256526", "3004102403", "2050010", "3016438761", "3007490412", "9610816", "3009156722", "3003637681", "3003971136", "3002807968", "3014506106", "3005509212", "3000126629", "2431530", "3006198300", "3037000637", "3007603826", "3005333358", "1319436", "3009473156", "3000148879", "3011989923", "2085064", "3016244760", "2432235", "8020316", "2221819", "3002809144", "3013513377", "9612296", "2050012", "9680746", "3012817228", "2247288", "1616487", "2250051", "1000455123", "3003030793", "3002642396", "9614698", "3004438098", "1220972", "3010825766", "1319681", "1222035", "3010324880", "3012963943", "1217183", "3023162659", "3004493545", "3004959793", "3014607865" ], "fei_number": [ "", "1000206808", "3008244372", "3004378326", "1036362", "2939693", "1000120319", "1827821", "3000308930", "1220649", "1000414342", "3002637618", "1181121", "3023268435", "2517506", "3003795116", "3005643513", "1000122044", "1036223", "1219913", "3003593973", "1317202", "1219029", "3002806560", "3007019572", "3002807167", "3003559576", "2245578", "1717966", "3007662974", "1000256526", "3004102403", "2050010", "1000305840", "3016438761", "1000135102", "3007490412", "1000136573", "3000215862", "3009156722", "3003637681", "3003971136", "3002808382", "3002807968", "3014506106", "3005509212", "3002806809", "3000126629", "2431530", "3006198300", "3037000637", "3002807663", "3007603826", "3005333358", "3009473156", "3000148879", "3011989923", "3016244760", "2432235", "2221819", "3002809144", "3013513377", "3001576181", "2050012", "3002806693", "3012817228", "1616487", "3002806559", "2250051", "1000455123", "3003030793", "3002642396", "3004438098", "1220972", "3010825766", "1222035", "3010324880", "3012963943", "1217183", "3023162659", "3004493545", "3004959793", "3014607865" ] } } ] }