{ "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": "150626", "product_res_number": "Z-0587-2017", "event_date_initiated": "2016-10-04", "event_date_created": "2016-11-16", "recall_status": "Terminated", "event_date_terminated": "2019-05-31", "res_event_number": "75513", "product_code": "CEM", "k_numbers": [ "K121012" ], "product_description": "FlexLab, Accelerator a3600 and Aptio Automation are modular systems designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory.\nThe systems consolidate multiple Analytical instruments into a unified workstation.", "code_info": "Shucko Socket with P/N: 693822160, Model: CMSA/HETTICH - STORAGE - i2000SR, Length: 3 meters; Shucko Socket with P/N: 693822170, Model: CMSA/HETTICH - STORAGE - i2000SR, Length: 5 meters; Shucko Socket with P/N: 693822190, Model: CMSA/HETTICH - STORAGE - i2000SR, Length: 7 meters; Shucko Socket with P/N: 0C00005640, Model: CMSA/HETTICH - STORAGE - i2000SR, Length: 2 meters.  The Serial number of the impacted products globally distributed are the following: ACP.009, ACP.024, ACP.039, ACP.054, ACP.069, ACP.084, ACP.100, ACP.115 , ACP.010, ACP.025, ACP.040, ACP.055, ACP.070, ACP.085, ACP.101, ACP.116, ACP.011, ACP.026, ACP.041, ACP.056, ACP.071, ACP.086, ACP.102, ACP.117, ACP.012, ACP.027, ACP.042, ACP.057, ACP.072,ACP.087, ACP.103, ACP.118 , ACP.013, ACP.028, ACP.043, ACP.058, ACP.073, ACP.088, ACP.104, ACP.119, ACP.014, ACP.029, ACP.044, ACP.059, ACP.074, ACP.089, ACP.105, ACP.120, ACP.015, ACP.030, ACP.045, ACP.060, ACP.075, ACP.090, ACP.110, ACP.121, ACP.016, ACP.031, ACP.046, ACP.061, ACP.076, ACP.091, ACP.107, ACP.122 ,ACP.017, ACP.032, ACP.047, ACP.062, ACP.077, ACP.092, ACP.108, ACP.123 ,ACP.018, ACP.033, ACP.048, ACP.063, ACP.078, ACP.093, ACP.109, ACP.124, ACP.019, ACP.034, ACP.049, ACP.064, ACP.079, ACP.094, ACP.110, ACP.125, ACP.020, ACP.035, ACP.050, ACP.065, ACP.080, ACP.096, ACP.111, ACP.126 ,ACP.021, ACP.036, ACP.051, ACP.066, ACP.081, ACP.097, ACP.112, ACP.127 , ACP.022, ACP.037, ACP.052, ACP.067, ACP.082, ACP.098, ACP.113, ACP.128, ACP.023, ACP.038, ACP.053, ACP.068, ACP.083, ACP.099, ACP.114, ACP.129, FLX.103, FLX.0120, FLX.0131, FLX.0137, FLX.0143, FLX.0161, FLX.0166, FLX.0179, FLX.0104, FLX.0124, FLX.0134, FLX.0140, FLX.0152, FLX.0163, FLX.0175, FLX.0108, FLX.0125, FLX.0135, FLX.0141 FLX.0155, FLX.0164, FLX.0176, FLX.0115, FLX.0126, FLX.0136, FLX.0142, FLX.0158, FLX.0165, FLX.0178, AP2.0001, AP2.0004, AP2.0006, AP2.0008, AP2.0010, AP2.0012, AP2.0014, AP2.0003, AP2.0002, AP2.0005, AP2.0007, AP2.0009, AP2.0011, AP2.0013, AP2.0015, FLX.0008, FLX.0133, FLX.0149, FLX.0153, FLX.0159, FLX.0167, FLX.0170, FLX.0174, FLX.0069, FLX.0139, FLX.0150 FLX.0156, FLX.0162, FLX.0168, FLX.0172, FLX.0179, FLX.0132, FLX.0147, FLX.0151, FLX.0157, FLX.0166, FLX.0169, FLX.0173 ,FLX.0121, FLX.0138, FLX.0144, FLX.0145, FLX.0146, FLX.0148, FLX.0176 and FLX.0181.", "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": "Inpeco received several notifications from the field about burnt schuko sockets. The customers reported that some smoke was seen coming from the damaged sockets.", "root_cause_description": "Employee error", "action": "Inpeco sent an Urgent Field Safety Notice dated October 2016 for the Aptio Automation, the Accelerator a3600 and the FlexLab Shucko power cord cables to all affected US and foreign customers. The Urgent Field Safety Notice described the reason for the recalls and actions that should be taken.\n\nThe firm is requesting all customers to complete and return the Field Correction Effectiveness Check form attached to the Urgent Field Safety Notice letter within 7 days. The Urgent Field Safety Notice letter should be forwarded to affected departments or consignees.\n\nTo mitigate any possible risks to the laboratory users' health conditions due to the defective power cords Inpeco released a Technical Service Bulletin (TSB) addressed only to Field Service Engineer with the procedure which has to be performed in order to prevent other cases of damaged sockets. The FSE has to check visually the appearance of the Schuko female socket. If it is intact, without any detectable deformation nor melting the FSE has to verify that the terminals are correctly crimped into each single wire. If the female socket presents alterations, the socket has to be replaced with a new one. \n\nThe affected sockets will be destroyed.\nCustomers with questions were instructed to call (+41) 91 9118 258.", "product_quantity": "188 units", "distribution_pattern": "Worldwide Distribution - US including Texas and New York. Foreign Consignees: Germany, Italy, France, Austria and Spain.", "openfda": { "k_number": [ "K800692", "K833696", "K912649", "K112408", "K853068", "K241037", "K843239", "K042291", "K900300", "K851350", "K833776", "K791692", "K974784", "K870657", "K112412", "K897110", "K901041", "K915178", "K092849", "K993083", "K883240", "K840887", "K884769", "K895664", "K013373", "K010061", "K843454", "K854723", "K042270", "K844806", "K970330", "K922943", "K083680", "K110520", "K901039", "K932044", "K870033", "K121040", "K253491", "K851100", "K915177", "K851808", "K833159", "K802158", "K220396", "K790018", "K073157", "K842786", "K843008", "K854298", "K841575", "K844044", "K884566", "K850950", "K900788", "K961326", "K821822", "K915345", "K061107", "K842315", "K896692", "K060373", "K844955", "K853356", "K822441", "K811310", "K771837", "K061730", "K771118", "K830104", "K040750", "K840961", "K112788", "K800054", "K052914", "K093318", "K961115", "K112995", "K092686", "K800016", "K200544", "K923038", "K230890", "K791175", "K890792", "K121012", "K832036", "K853531", "K032311" ], "registration_number": [ "", "2432235", "3002809144", "3006198300", "3037000637", "1036362", "2939693", "1036223", "2085064", "1181121", "3005509212", "3023162659", "2517506", "3007603826", "3000308930", "1319681", "2050010", "2030861", "3004959793", "3003795116", "1319809", "2221819", "9610816", "9614673", "3023268435", "3009156722", "3002637618", "3014506106", "3011989923", "1000256526", "3007490412", "2245578", "3004378326", "8020888", "3004102403", "3012817228", "3005333358", "3012963943", "3004493545", "1220649", "3008244372", "3010825766", "3003030793", "2050012", "3002642396", "3005643513", "1219913", "3000126629", "1616487", "1222035", "9610126", "3007662974", "1317202", "2250051", "2247288", "8030478", "9612296", "3003593973", "9614698", "9610529", "3004438098", "1319436", "1219029", "1220972", "9610633", "3002807968", "1000414342", "1827821", "2431530", "3014607865", "3009473156", "1000455123", "9680746", "3013513377", "3003637681", "3016438761", "1217183", "3010324880", "3000148879", "1717966", "8020316", "3003971136", "3016244760" ], "fei_number": [ "", "2432235", "1000120319", "1000206808", "3002809144", "3006198300", "3037000637", "1036362", "2939693", "3001576181", "1036223", "1000135102", "3005509212", "1181121", "3023162659", "2517506", "3002806693", "3007603826", "3000308930", "2050010", "3002807167", "3004959793", "3003795116", "2221819", "3023268435", "3009156722", "3002637618", "3014506106", "3011989923", "1000256526", "3007490412", "3003559576", "2245578", "3004378326", "1000305840", "3004102403", "3012817228", "1000122044", "3005333358", "3012963943", "3004493545", "1220649", "3008244372", "3010825766", "3007019572", "3003030793", "3002806559", "2050012", "3002807663", "3002642396", "3005643513", "1219913", "3000126629", "1616487", "1222035", "3007662974", "1317202", "2250051", "3003593973", "3004438098", "1219029", "1220972", "3002806809", "3002807968", "1000414342", "1827821", "3000215862", "2431530", "3014607865", "3009473156", "1000455123", "3002806560", "3013513377", "1000136573", "3003637681", "3016438761", "1217183", "3010324880", "3000148879", "1717966", "3003971136", "3002808382", "3016244760" ], "device_name": "Electrode, Ion Specific, Potassium", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.1600", "device_class": "2" } } ] }