{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "179410", "product_res_number": "Z-1421-2020", "event_date_initiated": "2020-01-12", "event_date_posted": "2020-03-02", "recall_status": "Open, Classified", "res_event_number": "84788", "product_code": "JGS", "k_numbers": [ "K161954" ], "product_description": "Atellica CH Reaction Ring Segment, SMN 11099326, UDI 00630414596143", "code_info": "Lots N1521417\tN1522218 N1528917\tN1526418 N1502518\tN1527518 N1503218\tN1529618 N1503918\tN1530318 N1504618\tN1531018 N1516318\tN1531618 N1517218\tN1532318 N1518318\tN1535518 N1519418\tN1536318 N1520118\t  ***new lots added 3/2/2020***  N1500119 \tN1520519  N1500219 \tN1521319  N1500620 \tN1522419  N1501119 \tN1523319  N1501520 \tN1526719  N1503519 \tN1527619  N1505619 \tN1528719  N1506419 \tN1529619  N1507919 \tN1533819  N1508519 \tN1534719  N1510619 \tN1535719  N1519019 \tN1530419  N1519719", "firm_fei_number": "2432235", "recalling_firm": "Siemens Healthcare Diagnostics, Inc.", "address_1": "511 Benedict Ave", "city": "Tarrytown", "state": "NY", "postal_code": "10591-5005", "additional_info_contact": "Aarti Aziz\n914-656-9027", "reason_for_recall": "Some lots ending in \"17\", \"18\", \"19\", or higher may have cuvette defects allowing water from the water bath to contaminate the interior of the cuvette, which may falsely elevate or depress sample results.", "root_cause_description": "Under Investigation by firm", "action": "The firm distributed Urgent Medical Device Correction letters to all affected customers on January 17, 2020. Customers were asked to check each Atellica CH 930 Analyzer in their laboratory as well as in their inventory for impacted cuvette lot numbers ending in \"17\" or \"18\" (6th and 7th digits). These devices must be purged from the customer's inventory. If the customer does not have enough cuvette segments of the unimpacted lot in their inventory, they may contact customer service. Detailed instructions were provided in the appendices to the customer letter.\n\n***Updated 3/2/2020***\nAn updated Urgent Medical Device Correction was distributed to all customers on February 26, 2020, due to the recalling firm adding cuvette segment kit lots ending in \"19\" to the affected products list. The follow-up communication advises customers of the potential for falsely depressed or elevated results from Atellica CH reaction cuvette segments with the kit lot ending in \"19\" and above, due to a cuvette defect allowing water bath to contaminate the cuvette.\n\nCustomers who routinely run the CO2_c assay will be instructed to run 300 replicates of the CO2_c calibrator on their analyzer in order to cover all cuvette positions. The customers will then follow the instructions provided in the communication and will use the mean value of the 300 replicates to determine if there is cuvette impact. If all individual calibrator results are d12% of the mean calibrator value, no further action is required, and the laboratories can continue to process patient samples. If any individual calibrator result is >12% of the mean calibrator value, customers will be asked to contact Siemens Customer Care Center to determine additional action to be taken prior to processing patient samples.\n\nCustomers who do not routinely run CO2_c samples in their laboratory will be instructed to run all patient samples in duplicate for every assay except Sodium, Potassium, and Chloride. Customers will be asked t", "product_quantity": "3559", "distribution_pattern": "Domestic distribution nationwide. Worldwide foreign distribution.", "openfda": { "k_number": [ "K903188", "K933373", "K875263", "K912387", "K801795", "K871028", "K801882", "K915176", "K921937", "K061597", "K905264", "K153357", "K252475", "K832744", "K873074", "K901040", "K841417", "K924471", "K935120", "K180428", "K880917", "K822039", "K020364", "K863907", "K872716", "K912560", "K863521", "K910554", "K082462", "K961099", "K181201", "K905600", "K213486", "K924547", "K070104", "K833992", "K993211", "K800584", "K992842", "K040977", "K863617", "K992844", "K842025", "K800628", "K841424", "K121140", "K171476", "K830589", "K040971", "K023049", "K002407", "K882801", "K901042", "K843453", "K140373", "K853832", "K963763", "K850209", "K990036", "K172232", "K191365", "K802155", "K151767", "K791691", "K053110", "K161954", "K220977", "K861967", "K102647", "K896526", "K873126", "K880750", "K921718", "K903564", "K844559", "K771839", "K864862", "K904335", "K912559", "K830588", "K941400", "K912648", "K861087", "K922215", "K914810", "K840557", "K874832", "K230275", "K811289", "K852595", "K864872", "K963627", "K100829", "K932179", "K910305", "K894218", "K872190", "K832415", "K801896", "K925611", "K222438", "K962334", "K810135", "K102959", "K892500", "K160370", "K002855", "K770601", "K874185", "K100673", "K052724", "K861696", "K925612", "K161837", "K955375", "K852473", "K955374", "K053165", "K801011", "K183688", "K870183", "K123726", "K963542", "K894914", "K881255", "K051646", "K091861", "K842873", "K820395", "K160225", "K800216", "K000895", "K862819", "K811896", "K894035", "K882104", "K844587", "K801007", "K833712", "K912016", "K200403", "K832070", "K081411", "K933862", "K132418", "K841418", "K990346", "K843530", "K800676", "K011213", "K940194", "K001154", "K895936", "K895672", "K833072", "K001761", "K952179", "K183549", "K812762", "K833036", "K843452", "K923806" ], "registration_number": [ "3005643513", "3014607865", "2050010", "3009156722", "3002807968", "3023268435", "1220972", "2221819", "9610633", "1616487", "8030478", "2085064", "3013513377", "9610126", "1319809", "3037000637", "2517506", "3003637681", "9610529", "2030861", "9610816", "3007662974", "9614673", "1220649", "2432235", "3003593973", "2939693", "3002642396", "3000308930", "3014506106", "8020888", "9612296", "3004959793", "3004438098", "1222035", "3003795116", "3016244760", "3004378326", "3007490412", "3002809144", "3010324880", "3012104670", "3004493545", "1000414342", "1000256526", "3008244372", "1717966", "3011989923", "3005509212", "1217183", "1036362", "3012817228", "3004102403", "3009473156", "2431530", "3007603826", "1181121", "1036223", "1219913", "1319681", "3003030793", "8020316", "3015997711", "2245578", "3002637618", "3000126629", "1827821", "3008629785", "1000455123", "1317202", "3000148879", "3010825766", "3016438761", "3012963943", "1319436", "2050012", "3023162659", "2250051", "9614698", "9680746", "2247288", "3006198300", "3005333358", "1219029", "3002807877", "3003971136" ], "fei_number": [ "1000206808", "3005643513", "3014607865", "2050010", "3009156722", "3002807968", "3023268435", "1220972", "2221819", "1616487", "3002806693", "3013513377", "3003559576", "3037000637", "2517506", "3003637681", "1000136573", "3002806559", "3002808382", "1000122044", "3007662974", "1220649", "2432235", "3003593973", "2939693", "3002806809", "1000305840", "3002642396", "3000308930", "3014506106", "3004959793", "3004438098", "1222035", "3000215862", "3003795116", "3016244760", "3004378326", "3007490412", "3002809144", "3010324880", "3012104670", "3004493545", "1000414342", "1000256526", "3008244372", "1717966", "3011989923", "3002807167", "3005509212", "1217183", "1036362", "3012817228", "3004102403", "3009473156", "2431530", "3002806560", "3007603826", "1181121", "1036223", "1000120319", "3007019572", "1219913", "3003030793", "3015997711", "2245578", "3002807663", "3002637618", "3000126629", "1827821", "3008629785", "1000455123", "1317202", "1000135102", "3000148879", "3010825766", "3016438761", "3012963943", "3001576181", "2050012", "3023162659", "2250051", "3006198300", "3005333358", "1219029", "3002807877", "3003971136" ], "device_name": "Electrode, Ion Specific, Sodium", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.1665", "device_class": "2" } } ] }