{ "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": "2026-10-29", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "221731", "product_res_number": "Z-0200-2027", "event_date_initiated": "2026-07-29", "event_date_posted": "2026-10-21", "recall_status": "Open, Classified", "res_event_number": "99518", "product_code": "JKA", "k_numbers": [ "K960857" ], "product_description": "Brand Name: VACUETTE\nProduct Name: LH Lithium Heparin Separator\nModel/Catalog Number: 454008P\nProduct Description: Greiner VACUETTE Blood Collection Tube with Lithium Heparin and Gel Separator (13 x 75 mm, 3.5ml)", "code_info": "Lot Code: Item Number: 454008P\nLot Number: B26043FM\nUDI: Rack: 29120017579032, Case: 39120017579039\nExpiration Date: 2027-07-12", "firm_fei_number": "3001451379", "recalling_firm": "Greiner Bio-One North America, Inc.", "address_1": "4238 Capital Dr", "city": "Monroe", "state": "NC", "postal_code": "28110-7681", "additional_info_contact": "Angela Drysdale\n001-704-7768646", "reason_for_recall": "Lot B26043FM may include EDTA contamination which introduces potassium while chelating calcium in patient samples, leading to falsely elevated potassium (K+) and falsely decreased calcium (Ca++) results which have the potential to cause hyperkalemia.", "root_cause_description": "Nonconforming Material/Component", "action": "On 07/29/2026, an \"URGENT MEDICAL DEVICE RECALL NOTICE\" was emailed to customers informing them that, Greiner Bio-One North America identified a potential ethylenediaminetetraacetic acid (EDTA) contamination issue in a specific lot of VACUETTE Lithium Heparin serum separator tubes. Use of affected tubes may lead to:\n\" Falsely elevated potassium (K+) results\n\" Falsely decreased calcium (Ca++) results\n\nCustomers are instructed to:\n\" Immediately identify and quarantine all remaining units of item 454008P, lot B26043FM.\n\" Stop using the affected lot for blood collection.\n\" Notify relevant staff (phlebotomy, lab, clinical teams) of this advisory.\n\" Review any recent patient results obtained using this lot. Consider repeat testing with a\ndifferent lot if results appear inconsistent with clinical presentation.\n\" Follow proper order of draw, and recollection procedures when re-testing.\n\nFor unused product disposal (if destroyed by customer/distributor)\n\" The unused blood collection tubes contain chemical additives (LH and serum\nseparator). Recommend following OSHA process, and/or your facility's environmental\nhealth and safety (EHS) policies and procedures for disposal.\n\nFor questions or documentation (Acknowledgement and Receipt Form) to\nRecalls.US@gbo.com or please call 800-515-8112.", "product_quantity": "860450", "distribution_pattern": "U.S. Nationwide distribution in the states of CO, FL, IL, MO, NE, NY, OH, PA, and VA.", "openfda": { "k_number": [ "K011699", "K133303", "K160657", "K222141", "K840496", "K900309", "K914129", "K935564", "K021941", "K093910", "K953994", "K030815", "K193569", "K252344", "K200027", "K883320", "K192247", "K172763", "K120490", "K142946", "K982998", "K892665", "K063852", "K213953", "K232881", "K162233", "K193074", "K964698", "K023331", "K810816", "K911809", "K890109", "K935588", "K924365", "K831242", "K833312", "K231237", "K220677", "K244047", "K213718", "K241586", "K971111", "K851506", "K900726", "K924364", "K201237", "K041071", "K252506", "K230855", "K992244", "K881201", "K922342", "K260857", "K971236", "K123987", "K223854", "K910646", "K902709", "K945454", "K880594", "K101502", "K060364", "K212019", "K971239", "K991120", "K944083", "K212724", "K023075", "K220799", "K991843", "K980414", "K953463", "K864863", "K251812", "K231282", "K021698", "K062932", "K000777", "K181754", "K991702", "K944618", "K982999", "K770107", "K233979", "K182078", "K962158", "K802211", "K022426", "K213690", "K223810", "K830472", "K896206", "K190485", "K213146", "K230391", "K884111", "K072783", "K043143", "K091292", "K945353", "K974873", "K252378", "K122355", "K971220", "K924361", "K921806", "K863491", "K222478", "K002456", "K831081", "K823176", "K945952", "K944566", "K250907", "K902442", "K962931", "K831719", "K933401", "K952516", "K950432", "K931367", "K993787", "K880622", "K051019", "K090737", "K103041", "K982922", "K262215", "K823836", "K220900", "K965202", "K981973", "K792587", "K063357", "K983517", "K781629", "K181895", "K153309", "K882539", "K093972", "K981035", "K884807", "K152924", "K260128", "K863976", "K884970", "K960858", "K041358", "K181743", "K231373", "K030596", "K081929", "K983952", "K202188", "K941159", "K201009", "K923090", "K974374", "K022875", "K991551", "K942241", "K040107", "K981013", "K191832", "K243207", "K223323", "K983490", "K250961", "K980098", "K163073", "K913399", "K790485", "K002777", "K960250", "K220212", "K922445", "K220458", "K921520", "K012221", "K232781", "K230865", "K252899", "K230408", "K935081", "K945777", "K242320", "K252040", "K901449", "K822508", "K893613", "K811036", "K901756", "K030394", "K202446", "K900856", "K061979", "K940905", "K222299", "K931924", "K991088", "K190604", "K922343", "K883813", "K931368", "K792723", "K864866", "K812285", "K960857", "K030573", "K030076", "K791303", "K220258", "K820717", "K202325", "K013971", "K910970", "K243649", "K924363", "K911638", "K081229", "K882614", "K936240", "K942240", "K954592", "K802209", "K230080", "K810664", "K915814", "K023971", "K022130", "K122687", "K926253", "K232308", "K960860", "K853152", "K924362", "K163508", "K833475", "K945245" ], "device_name": "Tubes, Vials, Systems, Serum Separators, Blood Collection", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.1675", "device_class": "2", "registration_number": [ "", "3006950086", "3014312726", "1219611", "1054241", "9613662", "1915484", "3044466317", "2321034", "3013298431", "1060680", "3013652330", "3010131137", "3026940910", "3038356900", "8010026", "3015309643", "2018685", "3005587132", "9617032", "3029901632", "3015972753", "3013696225", "2916714", "2434982", "9615588", "3009732568", "1710034", "1055236", "1423455", "3010515547", "3015485283", "3015173212", "3013517171", "3020831613", "9681835", "3022964615", "3031789039", "1054811", "3018507299", "1921846", "3008449424", "3015620563", "3009518015", "3004425647", "3043051314", "2245437", "3012104670", "8021764", "3041276591", "2024311", "3010187826", "1000487132", "3009976527", "3022728142", "8023060", "2032098", "3004140833", "3036773433", "3010419931", "3005910889", "9610847", "3020294761", "3006285950", "3009742443", "9611446", "3000268902", "3010405396", "3014680809", "3013248161", "3019807891", "9617475", "1043214", "3013221738", "3017406698", "3009495876", "3004824601", "3013055489", "3003120666", "3002807968", "1933913", "1319639", "3030896267", "1058584", "3022147580", "3011287770", "3015276780", "3012116434", "3012552122", "3030419987", "3007829657", "1423537", "3007490412", "3044026004", "1024879", "3043226252", "3008337059", "3011689956", "3012187973", "3033536319", "9680794", "3014570560", "3035708936", "2915274", "3037918935", "2243072", "9616567", "1125230", "2648045", "3013188547", "3014662855", "3008733163", "3008307705", "3010621964", "3028019212", "1917413", "8041187", "3031233007", "1055927", "3003895930", "3006191977", "3015997711", "3003974574", "3020460367", "2028807", "3017210488", "3010531069", "3010512490", "2032112", "1036781", "9681572", "3034667025", "3013187142", "1058602", "3002807408", "3005941719", "9680222", "3016844398", "2025816", "3030446844", "1647137", "3023228837", "3027553380", "3010421104", "3015453963", "3014263632", "3002637618", "3013513377", "2030624", "3010370650", "3008272066", "8020616", "2320762", "3004153557", "3008410596", "3003744503", "2648727", "3021169199", "8041145", "3016884191", "3009963993", "3007616112", "3047706961", "3001124136", "3010220595", "9614033", "2618282", "3008496607", "3010194621", "3024537844", "3010934635", "3006850222", "3012421607", "3014456066", "3012536737", "3019004087", "3004416208", "3006425876", "3017923561", "3001452053", "8020040", "3005674478", "3011088743", "3007135420", "3014654360", "1423507", "3005670221", "3014579161", "2032521", "1226230", "3014162214", "3030626857", "9615908", "3012494290", "1911916", "3012809732", "3012502601", "3015058854", "3016661372", "1930987", "3017509841", "3009889060", "1832216", "3030733800", "3010352064", "3016904853", "1036836", "1220477", "3042871620", "1047843", "3033589330", "1531062", "3039435934", "3002682307", "9680448", "3004597845", "3013557562", "3012598266", "3030243919", "3000247873", "9617604" ], "fei_number": [ "", "3002919051", "3006950086", "3014312726", "3003560965", "1219611", "3000206435", "1915484", "3044466317", "1000208624", "3013298431", "3013652330", "3010131137", "3026940910", "3038356900", "2018685", "3015309643", "3005587132", "1000306068", "3029901632", "3015972753", "3013696225", "2916714", "2434982", "1710034", "3009732568", "3010515547", "3015485283", "3015173212", "3013517171", "3010165944", "1000138054", "3020831613", "3003737899", "1000174591", "3022964615", "3031789039", "3000974732", "3018507299", "1921846", "3000191104", "3008449424", "3015620563", "3009518015", "3002963732", "3004425647", "3043051314", "2245437", "3012104670", "3001451379", "3041276591", "2024311", "3010187826", "3001236905", "3008002452", "3009976527", "1000487132", "3022728142", "3003992026", "3004140833", "3004552864", "3036773433", "3010419931", "3005910889", "3020294761", "3009742443", "3013248161", "3010405396", "3000268902", "3014680809", "2649711", "3002879021", "2828", "3019807891", "3003058448", "3011649541", "1043214", "3002974635", "3013221738", "3017406698", "3003399884", "3009495876", "3004824601", "1000219614", "3013055489", "3003120666", "3002807968", "1000112877", "3002836339", "3030896267", "3022147580", "3003886545", "3011287770", "3015276780", "3003752255", "3012116434", "3012552122", "3030419987", "3007829657", "1000219637", "3007490412", "3044026004", "1024879", "3043226252", "3008337059", "3011689956", "3002558692", "3003154916", "3003076831", "3012187973", "3033536319", "3014570560", "3035708936", "2915274", "3037918935", "2243072", "1000112968", "2648045", "3013188547", "3002806485", "3014662855", "3008733163", "3008307705", "1000113359", "3010621964", "3028019212", "3002806476", "1917413", "3031233007", "3002807725", "3003263857", "3003974574", "3006191977", "3015997711", "3020460367", "3017210488", "3001451226", "3010531069", "3010512490", "3034667025", "3013187142", "3002807408", "3016844398", "1000114185", "2025816", "3030446844", "3023228837", "3027553380", "3010421104", "3015453963", "3014263632", "3002637618", "3013513377", "3008272066", "3003282181", "3004153557", "3008410596", "3003744503", "3002808075", "2648727", "3021169199", "1000374126", "3016884191", "3009963993", "3002768455", "3007616112", "3047706961", "3001124136", "3010220595", "3008496607", "3010194621", "3024537844", "3010934635", "3006850222", "3012421607", "3014456066", "3012536737", "3019004087", "3004416208", "3006425876", "3017923561", "3001452053", "3005674478", "3011088743", "3007135420", "3014654360", "3003574398", "3005670221", "3014579161", "3014162214", "1000232458", "1000111918", "3030626857", "3012494290", "1911916", "3012809732", "3012502601", "3015058854", "3016661372", "3003040625", "1930987", "3017509841", "3009889060", "1832216", "3030733800", "3010352064", "3016904853", "1036836", "3002807111", "1220477", "3042871620", "1047843", "3033589330", "3000206414", "3039435934", "3002682307", "3004597845", "3013557562", "3012598266", "3030243919", "3000247873" ] } } ] }