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Nombre Clasificación Fabricante Nivel de riesgo País Fuente
Commercial Name: Angiography Equipment. Technical Name: Angiography Equipment. ANVISA registration number: 10234230075; 10234230093; 10234230096; 10345162023. Class of risk: III. Model affected: AXIOM Artis FC (Record: 10234230075); AXIOM Artis FA (Record: 10234230093); AXIOM Artis dFC, AXIOM Artis dFA (Record: 10234230096); Artis zee floor, Artis zee ceiling, Artis zee biplane, Artis zeego, Artis Q ceiling, Artis Q biplane, (Registration: 10345162023). Serial numbers affected: 3002; 3006; 4004; 3051; 4019 and 4022 Siemens Healthcare Diagnósticos S.A; Siemens AG; Siemens Healthcare GmbH Brazil ANVISA
Business Name: Heartware-Ventricular Assist System. Technical Name: Other Cardiovascular Implants. ANVISA registration number: 80583400001. Hazard class: IV. Model Affected: No Model .. Serial Numbers Affected: BATTERY LT: 1650,1650DE - BAT000001 to BAT039999; BAT090000 to BAT099999 Endotec Produtos Médicos Ltda; Heartware Inc. Brazil ANVISA
Trademark: IntelliVue iX Information Center. Technical Name: Software. Registration number ANVISA: 10216710250. Risk class: III. Affected Model: M3290B .. Number of Series Affected: 5750-5JHY-H; 087W-4VK7-W; 6W4K-0GN9-A; 453E-1AHM-H; 7216-59N8-6; 7R0L-6AMX-B; 5G75-5WKF-8; 745P-55J9-R; 3H1F-42GL-N; 0R3L-5PP3-T; 3N4R-43JR-A; 2N H-7HN-N; 5W0N-4FL0-2; 5K15-0MNA-D; 005J-0ZNF-1; 5636-61K2-R; 4V6P-2XHV-X; 2A1H-7HJU-U; 312C-5MGJ-2; 2C49-12JD-P; 5F5Y-11KG-C; 7B7G-2UGW-5; 7J34-24GX-T; 2W76-3ZKP-P; 597Y-7BG9-Y; 1W5W-66H9-W; 2E4R-43JR-3; 7V5H-1YML-2; 204 D-2HJF-P; 412W-1VNP-R; 0K52-6KKD-7; 6A78-1LMN-3; 6F2P-1RHT-T; 0T6R-3KLU-9; 080V-7AHH-6; 6W33-5BNT-X Philips Medical Systems Ltda. Brazil ANVISA
Commercial Name: Architect Dhea-S Reagent Kit / Architect Dhea-S Reagent Kit. Technical Name: Dehydroepiandrosterone Sulfate (DHEA-S). ANVISA registration number: 80146501346. Class of risk: II. Affected Model: Not applicable. Serial Numbers Affected: 01316K000; 01217A000; 02217D000; 04117H000; 01216K000; 01117A000; 02217C000; 02317D000; 02417D000; 00517F000 Abbott Laboratórios do Brasil Ltda; Abbott GmbH & Co. KG. Brazil ANVISA
Trade name: Hemoglobin A1C. Technical Name: Hemoglobin. ANVISA registration number: 80146501853. Class of risk: II. Affected Model: Not Applicable. Serial Numbers Affected: 50007UQ10; 50030UQ10; 50279UQ12; 50280UQ12; 50281UQ12; 50282UQ12; 50613UQ02; 50614UQ02; 50615UQ02; 50616UQ02; 50884UQ04; 51177UQ06 Abbott Laboratórios do Brasil Ltda; Abbott Laboratories Brazil ANVISA
Trade name: OptiView DAB IHC Detection Kit; Ultraview Universal DAB Detection Kit; OptiView Amplification Kit and Hematoxylin II. Technical Name: Immunohistochemistry - Complementary Reagents. ANVISA Registration Number: 10287410832. Hazard Class: I. Affected Model: N / A .. Serial Numbers Affected :. >> Lots Affected Distributed by Roche Diagnóstica Brazil :. OptiView DAB IHC Detection Kit = Lot Y11625. UltraView Universal DAB Detection Kit = Y09284. OptiView Amplification Kit = Lot Y15435. Hematoxylin II = Lot Y13938. >> Lots Affected in Stock in Roche Disgnóstica Brazil :. OptiView DAB IHC Detection Kit = Lots Y11625; Y15571; Y19271. ultraView Universal DAB Detection Kit = Lots Y09284; Y11687; Y15384; Y17984; Y18099. OptiView Amplification Kit = Lot Y15435. Hematoxylin II = Lots Y13938; Y17402; Y17403. NOTE: In the origin (manufacturer) there are other materials and lots affected, but that have not been imported by Brazil so far. Hematology and Pathology Devices Roche Diagnóstica Brasil Ltda.; Ventana Medical Systems, Inc. Brazil ANVISA
Commercial Name: IMMULITE 2000 Universal IgG Specific IgG Allergen Kit. ANTI-HBc IMMULITE 2000; BR-MA (CA15-3) IMMULITE; BR-MA (15.3) Immulite 2000; CEA IMMULITE; CEA IMMULITE 2000; CK-MB IMMULITE; CK - MB IMMULITE 2000; EPO IMMULITE; EPO IMMULITE 2000; FOLIC ACID IMMULITE 2000; IMMULITE GASTRINE / IMMULITE 1000; GASTRINA IMMULITE 2000; OM - MA IMMULITE; OM-MA IMMULITE 2000; THYROGLOBULIN IMMULITE; THYROGLOBULIN IMMULITE 2000; VITAMIN B12 IMMULITE / IMMULITE1000. Technical Name: IMMULITE 2000 Universal IgE Specific IgG Kit 3g. ANTI-HBc IMMULITE 2000; BR-MA (CA15-3) IMMULITE; BR-MA (15.3) Immulite 2000 ;. CEA IMMULITE; CEA IMMULITE 2000; CK-MB IMMULITE; CK-MB IMMULITE 2000 ;. EPO IMMULITE; EPO IMMULITE 2000; FOLIC ACID IMMULITE 2000 ;. IMMULITE GASTRINE / IMMULITE 1000; GASTRINA IMMULITE 2000; OM - MA IMMULITE ;. OM-MA IMMULITE 2000; THYROGLOBULIN IMMULITE; THYROGLOBULIN IMMULITE 2000; VITAMIN B12 IMMULITE / IMMULITE1000. ANVISA registration number :. 10345160916. 10345160914. 10345160914. 10345160814. 10345160812. 10345160812. 10345161894. 10345160745. 10345160727. 10345160827. 10345160712. 10345160718. 10345160916. 10345160916. 10345161009. 10345160877. 10345160871. 10345160825. Risk class (Sequential order of the registration number). II. IV. III. III. III. III. III. III. II. II. II. II. II. III. III. II. II. II. . Affected Model: N / A .. Serial Numbers Affected:. REAG ALLERGY UNIV IGE 600T (IMM2000): 447; 448; 450; 451; 453; 456; 457; 458; 459; 461; 462; 465; 466; 468; 469 .. FOLIC ACID REAGENT 200T (IMM2000): 494; 496; 498; 502; 503; 505; 506; 508 .. REAGENT FOLIC ACID 600T (IMM2000): 492; 495; 497; 504 .. ANTI-HBC 200T REAGENT (IMM2000): 577; 578; 579; 580. REAGENT BR-MA 15.3 200T (IMM2000): 262; 263; 264; 265; REAGENT CEA 100T (IMM1000): 353; 354; 355; REAGENT CEA 200T (IMM2000): 307; 308; 309; 310; 311; REAGENT CEA 600T (IMM2000): 307; 308; 309; 310; 311 .. REAGENT CKMB 100T (IMM1000): 342; 343; 344; REAGENT CKMB 200T (IMM2000): 238; 239; EPO MONO REAGENT (IMM1000): 343; 347. EPO MONO REAGENT (IMM2000): 246; 247; 248; 249; 250; 251; 252 .. REAGENT GASTRINE 200T (IMM2000): 248; 249; 250; 251; 252; 253; 254 .. OM-MA CA125 100T REAGENT (IMM1000): 209; 211; 212; 2013. REAGENT OM-MA CA125 200T (IMM2000): 285; 286; 287; REAGENT TIROGLOBULIN 100T (IMM1000): 286; 287; 288; 289; 290. TIROGLOBULIN REAGENT 200T (IMM2000): 340; 341; 342; 344; 345; 346; 347; 349; 351; 352; REAGENT VITAMIN B-12 100T (IMM1000): 336; 337; 338; 339; 340; Siemens Healthcare Diagnósticos Ltda.; Siemens Healthcare Diagnostics Products Ltd. Brazil ANVISA
Trade name: Sheath Prelude Introducer with Needle. Technical name: Introducers. ANVISA registration number: 80740950022. Class of risk: II. Model Affected: PSI-4F-11-018; PSI-4F-11-035; PSI-4F-7-018; PSI-5F-11-018; PSI-5F-7-018; PSI-6F-11-018; PSI-6F-11-035; PSI-6F-23-038; PSI-8F-23-035 .. Serial numbers affected: H802104; H806589; H806563; H829231; H869123; H848212; H861337; H910848; H835834; H869107; H916892; H957657; H964183; H957686; H964253; H985394; H985395; H998662; H998663; H985268; H985169; H971709; H978333; H957674; H991436; H1005204; H1005185; H1005186; H998648; H1014767; H1021017; H1028215; H1021246; H1041894; H888879; H978383; H1028221; H1035120; H1035143; H1035145; H1049148; H964219; H1049127; H1086779; H1064319; H1049137; H1071895; H1117323; H1117324; H1064320; H1070592; H1070597; H1117325; H1102033; H1101832; H1117326; H1125976; H1028219; H1101833; H1133413; H1109361; H1133441; H1117248; H1056694 Merit Medical Comercialização, Distribuição, Importação e Exportação de Produtos Hospitalares Ltda; Merit Medical System, INC Brazil ANVISA
Trade name: Sheath Prelude Introducer with Needle. Technical name: Introducers. ANVISA registration number: 80740950020. Risk class: II. Model Affected: PSI-5F-11-035-18G; PSI-5F-11-038-18G; PSI-7F-11-035-18G; PSI-8F-11-035-18G; PSI-8F-11-038-18G .. Serial numbers affected: H775538; H790718; H802113; H806577; H812866; H822603; H822602; H806605; H829277; H835873; H822736; H767850; H829297; H788043; H790744; H852837; H829246; H841190; H669686; H724631; H830254; H886443; H829247; H835846; H848377; H802159; H955521; H829301; H874601; H890316; H900044; H916861; H943490; H950221; H964205; H971723; H978305; H924297; H950258; H957690; H964259; H998674; H900066; H910903; H985755; H991635; H835954; H998744; H975409; H1005212; H854282; H861401; H869136; H910866; H916920; H930913; H937371; H943513; H971741; H1005235; H965173; H995197; H1005194; H985356; H1005213; H1014823; H1014824; H1014825; H1014862; H991686; H1035163; H1041903; H1021289; H1028268; H1035198; H1021268; H1028266; H991512; H998657; H1021251; H1049236; H1041935; H1057258; H1067690; H1014784; H1049235; H1068880; H1068890; H1057247; H1021180; H1028228; H1068889; H1035126; H1035190; H1071870; H1079023; H1086800; H1086801; H1041928; H1078982; H1117256; H1101868; H971742; H1049249; H1133399; H1101867; H1117337; H1071899 Merit Medical Comercialização, Distribuição, Importação e Exportação de Produtos Hospitalares Ltda; Merit Medical System, INC Brazil ANVISA
Trade name: Cobas 6500 - u 601 eu 701. Technical name: Instrument for urinalysis. ANVISA registration number: 80712710007. Risk class: III. Model Affected: N / A. Serial numbers affected: See attached list on Anvisa portal - link: http://portal.anvisa.gov.br/informacoes-tecnicas13/-/asset_publisher/WvKKx2fhdjM2/content/alerta-2471-tecnovigilancia-roche-foco-cirurgico- The following table summarizes the results of this study: - illumina-sample incompatibility / 33868? p_p_auth = PAWpHtof & inheritRedirect; = false & redirect; = http% 3A% 2F% 2Fportal.anvisa.gov.br% 2Final-techniques13% 3Fp_p_auth% 3DPAWpHtof% 26p_p_id% 3D101_INSTANCE_WvKKx2fhdjM2% 26p_p_lifecycle% 3D0% 26p_p_state% 3Dnormal% 26p_p_mode% 3Dview% 26p_p_col_id% 3Dcolumn-3% 26p_p_col_pos% 3D1% 26p_p_col_count% 3D5 Roche Diagnóstica Brasil Ltda.; Roche Diagnostics GmBH Brazil ANVISA
Trade name: Linear Accelerator Elekta. Technical Name: Linear Accelerator. ANVISA registration number: 80569320007. Risk class: III. Affected model: Integrity R1.2 .. Affected serial numbers: See list of affected lots attached in Anvisa portal - link: http://portal.anvisa.gov.br/informacoes-tecnicas13/-/asset_publisher/WvKKx2fhdjM2/content /home % 3DF% 3Dview% 3Dp% 3Dview% 26p_p_col_id% 3Dcolumn% 3pp% 3D2% 26p_p_col_count% 3D5% 26p_p_col_count% 3D5% 26p_p_col_count% 3D5% Elekta Medical Systems Comércio e Serviços Radioterapia Ltda; Elekta Ltd Brazil ANVISA
Trade name: Linear Accelerator Elekta. Technical Name: Linear Accelerator. ANVISA registration number: 80569320007. Risk class: III. Affected Model: Integrity ™. Serial numbers affected :. INTEGRITY SOFTWARE / 16966-001 / 3.2.0 ;. INTEGRITY SOFTWARE / 30000301-001 / 3.2.0. INTEGRITY SOFTWARE / 20391-001 / 3.2.0. INTEGRITY SOFTWARE / 30000515-002 / 3.2.0. INTEGRITY SOFTWARE / 30000683-001 / 3.2.0 Elekta Medical Systems Comércio e Serviços Radioterapia Ltda; Elekta Ltd Brazil ANVISA
Name: Anesthesia System Carestation. Technical Name: Anesthesia Device. ANVISA registration number: 80071260222. Class of risk: III. Model affected: All. Serial numbers affected: 9100c (ANVISA Register 80071260222) GE Healthcare do Brasil, Com. e Serv. para Equipamentos Médico-Hospitalares Ltda.; GE MEDICAL SYSTEMS (CHINA) CO., LTD Brazil ANVISA
Trade name: - BD Phoenix Gram Negative; BD Phoenix Gram Negative Panels. Technical Name: Microorganism Identification / Antibiogram Device. ANVISA registration number: 10033430636; 10033430734. Class of risk: II. Affected Model: BD Phoenix NMIC - 203; BD Phoenix NMIC / ID-94; BD Phoenix. Serial numbers affected: PX2049; PX2078; PX2120; PX2098; PX2063; PX2079; PX2097; PX2099; PX2121; PX2134 Becton Dickinson Indústrias Cirúrgicas Ltda.; Becton Dickinson and Company. Brazil ANVISA
Trade name: VITEK 2 AST family. Technical name: Identification device / antibiogram of microorganisms. ANVISA registration number: 10158120592. Class of risk: II. Affected model: VITEK 2 AST P585 and VITEK 2 AST P612. Affected serial numbers: Field action is not dependent batch. bioMperieux Brasil Ind e Com de Prod Laboratoriais Ltda; Biomérieux Inc Brazil ANVISA
Trade name: DS Aesculap Titanium Clips and DS Clip Clips. Technical name: DS Aesculap Titanium Clips and DS Clip Clips. ANVISA registration number: 80136990853. Class of risk: III. Affected Model: FC230R, PL462SU, PL465SU, PL468SU, PL471SU, PL475SU, PL807R, PL808R, PL809R, PL817R, PL818R. Affected serial numbers: The field action involves all batches of product, since it is a change in the "Contraindications" field of the Instructions for Use. Laboratórios B. Braun S.A.; Aesculap AG Brazil ANVISA
Product Name: HeartStart MRx Defibrillator. Technical Name: Defibrillator. ANVISA registration number: 10216710136. Class of risk: III. Model Affected: M3535A, M3536A. Affected serial numbers: US00205374; US00211784; US00537846; US00540022; US00546163; US00547369; US00560582; US00564384; US00564385; US00566641; US00566642; US00566689; US00566690; US00567001; US00567002; US00567003; US00567004; US00569420; US00576505; US00576506; US00576507; US00576569; US00576570; US00576571; US00576572; US00576573; US00576574; US00576575; US00576576; US00576577; US00576578; US00576579; US00576580; US00576581; US00576582; US00576583; US00576584; US00576585; US00576586; US00576587; US00576588; US00576589; US00576590; US00576591; US00576592; US00576593; US00576594; US00576595; US00576596; US00576597; US00576598; US00576599; US00576600; US00576601; US00576602; US00576603; US00576604; US00576605; US00576606; US00576607; US00576608; US00576609; US00576610; US00576611; US00579400; US00579401; US00579402; US00579403; US00579404; US00579405; US00579406; US00579407; US00579408; US00579409; US00579413; US00579414; US00579415; US00579416; US00579417; US00579418; US00579419; US00579420; US00579421; US00579422; US00579423; US00579424; US00579425; US00579426; US00579427; US00579428; US00579429; US00579430; US00579431; US00579432; US00579433; US00579434; US00579435; US00579436; US00579640; US00579501; US00579502; US00579503; US00579504; US00579497; US00584396; US00332060; US00584388 Cardiovascular Devices Philips Medical Systems Ltda Brazil ANVISA
Trade name: Lubrigel Intimate Lubricant. Technical Name: Intimate Lubricant. ANVISA registration number: 80005910023. Class of risk: II. Model affected: Sache 5g. Serial numbers affected: 17/0575; 17/0577; 17/0584; 17/0585; 17/0601; 17/0602; 17/0638; 17/0739; 17/0740; 17/0751; 17/0752; 17/0753; 17/0754; 17/0768; 17/0769; 17/0770; 17/0771; 17/0799; 17/0800; 17/0801; 17/0802 and 17/0803. Carbogel Indústria e Comércio Ltda Brazil ANVISA
Trade name: i-STAT KAOLIN ACT CARTRIDGE. Technical Name: Activated Coagulation Time. ANVISA registration number: 80146501500. Risk class: III. Affected Model: Not applicable. Serial Numbers Affected: R16354A; R17025; R17041; R17080; R17110; R17123; R17165; R17197; R17201A; R17197A; R17273; R15310; R15356; R16034; R16067; R16115; R16146; R16174; R16222; R16254; R16278; R16304; R16316; R17007; R17038; R17059; R17128; R17201; R17250; R17276; R17321 Abbott Laboratórios do Brasil Ltda; Abbott Laboratories Brazil ANVISA
Trade name: Surgical Focus Vol. Technical Name: Surgical Focus. ANVISA Registration Number: 80259110132. Hazard Class: I. Model Affected: Surgical Focus Volista Access .. Serial Numbers Affected: 36008; 38005; 38033; 38039; 500153; 35000; 36016; 38008; 38013; 38032; 38034; 38037; 500000; 500001; 500001; 500002; 500002; 500003; 500004; 500005; 500006; 500007; 500008; 500009; 500010; 500011; 500012; 500013; 500014; 500015; 500016; 1002; 36031; 36032; 36033; 36034; 36035; 36036; 36037; 36038; 36039; 36040; 38006; 38011; 38030; 38035; 38038; 38058; 38059; 38060; 38061; 38063; 38064; 38029; 38033; 38036; 500133; 36017; 36018; 38035; 38007; 38010; 38033; 38034; 500155; 31000; 38009; 38012; 38031; 38035; 38038; 20509; 500154 Maquet do Brasil Equipamentos Médicos Ltda; MAQUET SAS Brazil ANVISA
Laboratory tests using biotin technology assay methodologies to promote binding with specific protein biomarkers. N/A Brazil ANVISA
Trade name: Qualitas Gama. Technical Name: Motorized Bed. ANVISA Registration Number: 80509610013. Hazard Class: I. Model Affected: PA-66254 * XS. Serial numbers affected: 9010157-00003; 9010157-00004; 9010157-00018; 9010157-00007; 9010157-00015; 9010157-00017; 9010157-00002; 9010157-00008; 9010157-00006; 9010157-00016; 9010157-00013; 9010157-00001; 9010157-00012; 9010157-00005; 9010157-00019; 9010157-00011; 9010088-00005; 9010088-00011; 9010088-00007; 9010088-00014; 9010088-00001; 9010088-00015; 9010088-00003; 9010088-00008; 9010088-00009; 9010088-00006; 9010088-00002; 9010088-00010; 9010088-00012; 9010088-00004. Bed do Brasil Comércio de Equipamentos Médicos Ltda; PARAMOUNT BED CO., LTD.. Brazil ANVISA
Trade name: VIDAS - Automated System for the Execution of Laboratory Diagnostic Tests. Technical name: Instrument for immunoassays. ANVISA registration number: 10158120241. Risk class: I. Affected model: VIDAS / miniVIDAS System / VIDAS / miniVIDAS system Affected serial numbers: This field action is not a dependent batch. bioMerieux Brasil Ind e Com de Prod Laboratoriais Ltda; Biomerieux S.A. Brazil ANVISA
Technical Name: Angiography Equipment. ANVISA registration number: 10345162020. Risk class: III. Affected Model: Artis One. Serial Number Affected: 82190; 82235; 82176; 82062; 82032; 82197; 82187; 82046; 82030; 82136; 82200; 82063; 82090; 82092; 82170; 82216; 82048; 82110; 82143; 82084; 82058; 82067; 82161 Siemens Healthcare Diagnósticos Ltda; Siemens Shenzhen Magnetic Ressonance Ltd.(SSMR) Brazil ANVISA
Note (03/28/2018): Based on the 006/2018 / SCVSAT notification from the State Health Department of Paraná, the information on affected lots was rectified and this field action applies to the following lots: . Commercial Name: Protective Cover Bed; ANVISA registration number: 80670160004; Risk class: I; Affected Model: Protective Cover Camouflage Breathalyzer with Ring; Lot: 1702006, 1708033, 1709011 ... Commercial Name: Protective Cover Bed; ANVISA registration number: 80670160004; Risk class: I; Affected Model: Protective Cloak Breathable Videolaparoscopy Cover; Lot: 1709002 ... Commercial Name: Protective Cover Bed; ANVISA registration number: 80670160004; Risk class: I; Affected Model: Ultrasonic Tweezer Protective Cover; Lot: 1709003 ... Trade name: Artrolon Standard; ANVISA registration number: 80670160045; Risk class: II; Model Affected: Artrolon Standard 4V; Lot: 1702007 ... Trade Name: Auxiliary Table Field Bed; ANVISA registration number: 80670160001; Risk class: I; Model Affected: Auxiliary Table Field Bed 90x120cm; Lot: 1702010, 1702011, 1709001, 1709007 ... Trade name: Blue Field in TNT for Auxiliary Table Bed; ANVISA registration number: 80670160006; Risk class: I; Affected Model: Blue Field in TNT for Auxiliary Table Unclosed Bed 130x180cm; Lot: 1702012. Camahe Indústria e Comércio, Importação e Exportação de Produtos para Saúde Ltda. Brazil ANVISA