{ "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": "2026-09-20", "results": { "skip": 0, "limit": 1, "total": 5 } }, "results": [ { "cfres_id": "199273", "product_res_number": "Z-1559-2023", "event_date_initiated": "2023-03-10", "event_date_posted": "2023-05-04", "recall_status": "Open, Classified", "res_event_number": "91950", "product_code": "CEM", "k_numbers": [ "K121012" ], "product_description": "Input Output Module (IOM) FLX-201-Laboratory Automation system\n\nBrand names of the same product: FlexLab (FLX), Accelerator\na3600 (ACP), Aptio Automation (AP2)\n\nPart Numbers: \nFLX-201-00,\nAPT-201-00, APT-253-00\nACP-201-00,\nFLX-201-10, FLX-253-10, FLX-253-11", "code_info": "FlexLab\t07640172340004\nAccelerator a3600\t07640172341001\nAptio¿ Automation\t07640172342008\n\n\nFirmware Versions:\nGWC board: prior to 2-3-0.\nDDT board: all versions", "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 versions have the potential to mis-associate sample IDs leading to incorrect results or delayed sodium, potassium, and chloride patient results. Falsely increased or decreased electrolytes can lead to either inappropriate treatment of normal results, or failure to treat abnormal results resulting in abnormal levels. Abnormal potassium levels can result in weakness, polyuria, ileus, psychiatric disturbances, cardiac arrhythmias, respiratory depression, and death. Abnormal sodium levels can result in CNS disturbances and disturbances of water balance. Abnormal chloride levels can lead to acid base disturbances which can lead to respiratory and cardiac compromise. \n\nThe event may occur only if all the following conditions occurs in few milliseconds timeframe:\n- The module is releasing a sample tube (Tube A) just placed into the carrier\n- Another sample tube (Tube B) is erroneously not diverted into the module buffer lane due to a malfunction of the divert gate\nOnly in this specific scenario, the Tube A may be released by the module as Tube B due to a miscommunication between the module firmware and the Automation software without any error message.\n\nThe Automation System loses the traceability of Tube A. It manages both Tube A (incorrectly identified as Tube B) and the real Tube B according to the test orders not performed yet on Tube B.\n\nInpeco has released a Technical Service Bulletin with the procedure to correctly update the firmware. The firmware upgrade will be performed by Field Service Engineers. A CAPA (Corrective Action Preventive Action) has been opened to deeply investigate the root cause and identify possible process lack in order to avoid reoccurrences.", "root_cause_description": "Under Investigation by firm", "action": "Impeco issued Urgent: Medical Device Correction Letter for affected product: Flexlab/Accelerator a3600/Aptio Automation on 3/10/23 to US Distributors and Direct End Users via email. Letter states reason for recall, health risk and action to take:\nThe scenario occurs in the case of a divert malfunction ..\nTo avoid the occurrence of the described issue lnpeco recommends to visually check every day\nthe gates at the buffer lane entry of the impacted modules (refer to Image l.a and Image l.b) to\nverify that:\nthere are no obstructions that prevent the correct activation and movement of the divert;\nthe divert looks to be intact, refer to Image 2.a and Image 2.b;\nthe position of the divert is aligned to the profiles when it is diverting a tube, refer to Image 3.a and Image 3.b; tubes that need to be routed by the module are diverted fluidly, without any missing or partial block of the carrier.\n\nIf the visual check is not passed, contact your local technical support for assistance before using the Automation System impacted modules to process samples.\nYour service provider will contact you to schedule the firmware upgrade.\n\nUntil the service visit please maintain awareness on this notice and apply the actions\nrecommended above.\nPlease transfer this notice to whom it might concern.\nPlease complete and return the \"Customer Letter Receipt Confirmation and Implementation\nCheck\" form attached to this letter within 30 days directly to the email address specified in the\nemail communication.\nContact reference person:\nFor any clarification you may need, do not hesitate to contact:\nEva Balzarotti - Regulatory Affairs Manager\nE-maii:Eva.Balzarotti@inpeco.com\nPhone: (+41) 91 9118 224", "product_quantity": "US:245 (16 FlexLab systems, 121 Accelerator a3600 system, 108 Aptio Automation systems).", "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of ARGENTINA, AUSTRALIA, \nAUSTRIA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC,\nDENMARK, EAU, EGYPT, FRANCE, GERMANY, GREECE, HUNGARY, INDIA, IRELAND, ISRAEL, \nITALY, JAPAN, KENYA, MALAYSIA, MEXICO, MYANMAR, NETHERLANDS, NORWAY, OMAN, PAKISTAN, PORTUGAL, QATAR, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, \nUK, VIETNAM.", "openfda": { "k_number": [ "K884566", "K840887", "K771118", "K993083", "K901041", "K121012", "K771837", "K791692", "K897110", "K844044", "K853068", "K112995", "K010061", "K843239", "K830104", "K890792", "K042291", "K092849", "K200544", "K791175", "K844806", "K811310", "K832036", "K842315", "K112788", "K821822", "K800054", "K112408", "K800016", "K800692", "K851100", "K220396", "K970330", "K840961", "K822441", "K915345", "K042270", "K802158", "K833159", "K851808", "K896692", "K253491", "K870657", "K922943", "K833696", "K854298", "K842786", "K110520", "K901039", "K961115", "K932044", "K060373", "K833776", "K853531", "K895664", "K884769", "K230890", "K844955", "K013373", "K093318", "K032311", "K112412", "K853356", "K092686", "K961326", "K040750", "K915177", "K061107", "K790018", "K974784", "K241037", "K850950", "K900300", "K083680", "K851350", "K061730", "K883240", "K841575", "K052914", "K854723", "K843454", "K073157", "K912649", "K870033", "K923038", "K915178", "K121040", "K900788", "K843008" ], "device_name": "Electrode, Ion Specific, Potassium", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.1600", "device_class": "2", "registration_number": [ "1220972", "3002809144", "3000126629", "3037000637", "8020888", "9610816", "3010324880", "3012963943", "3002642396", "1000455123", "3016438761", "1036223", "1219913", "9610633", "3004493545", "9614698", "3009473156", "3004102403", "9614673", "2050012", "3000308930", "3023268435", "1717966", "3003030793", "1220649", "3008244372", "2245578", "2250051", "2432235", "3003593973", "3007490412", "2085064", "3010825766", "3004959793", "3005509212", "3011989923", "3012817228", "3009156722", "3016244760", "2939693", "2030861", "3007662974", "8020316", "3005146313", "3014506106", "9610529", "3003637681", "1217183", "2247288", "3007603826", "1319436", "1219029", "3004438098", "8030478", "3014607865", "3013513377", "3003795116", "3023162659", "9610126", "9612296", "2050010", "3002807877", "1222035", "3005333358", "1181121", "1000256526", "1319681", "1317202", "1827821", "1319809", "1000414342", "2431530", "3005643513", "9680746", "2517506", "3002637618", "3000148879", "3004378326", "1036362", "1616487", "3006198300", "3002807968", "3003971136", "2221819" ], "fei_number": [ "3007019572", "1220972", "3002809144", "3000126629", "3037000637", "3003559576", "1000305840", "3010324880", "3002806809", "3012963943", "3002642396", "1000455123", "3016438761", "3001576181", "1036223", "1219913", "3004493545", "3009473156", "3004102403", "2050012", "3000308930", "3023268435", "1717966", "3003030793", "1220649", "3008244372", "2245578", "1000122044", "2250051", "2432235", "3002807663", "3003593973", "3007490412", "3010825766", "3004959793", "3005509212", "3011989923", "3012817228", "3009156722", "3016244760", "2939693", "3007662974", "3000215862", "3002806560", "3005146313", "3014506106", "1000136573", "3003637681", "1217183", "1000135102", "3007603826", "1219029", "3004438098", "3014607865", "3013513377", "1000120319", "3003795116", "3023162659", "3002808382", "3002806559", "1000206808", "2050010", "3002807167", "3002807877", "1222035", "3002806693", "3005333358", "1181121", "1000256526", "1317202", "1827821", "1000414342", "2431530", "3005643513", "2517506", "3002637618", "3000148879", "3004378326", "1036362", "1616487", "3006198300", "3002807968", "3003971136", "2221819" ] } } ] }