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Manufacturers
Roche Diagnóstica Brasil Ltda.; Roche Diagnostics GmBH
Manufacturer Parent Company (2017)
Roche Holding Ag
Source
ANVSANVISA
16 Events
Safety Alert for Trade Name: MagNA Pure 24 System. Technical Name: Instrument for analysis of nucleic acids. ANVISA registration number: 10287411309. Risk Class: II. Model Affected: N / A. Serial numbers affected: Active: 1119 | Inventory: 1162
Safety Alert for Trade name: Elecsys Vitamin D total II. Technical name: Vitamin D. ANVISA registration number: 10287411273. Class of risk: II. Model Affected: N / A. Elecsys Vitamin D total II (100 tests) (Code: 7464215190 and Record: 10287411273) lots under risk in Brazil: 27398201/29822801 / 27398202. Elecsys Vitamin D total II (300 tests) (Code: 7028148190 and Registry: 10287411242) lots under risk in Brazil: 23010601/27396201
Safety Alert for Trading name: Cobas e801 Module. Technical name: Instrument for immunoassays. ANVISA registration number: 10287411196. Class of risk: II. Model affected: -. Lots / series numbers affected :. 1741-08 (Roche), 1765-02, 1766-04, 1766-05, 1768-07, 1768-08, 1768-09, 1767-08, 1768-10, 1767-07, 1772-04, 1771-03 , 1771-06, 1787-10, 1788-01, 1791-06, 1791-07, 1796-09, 1796-10, 1797-04, 1799-04, 1799-05, 18E0-04 (Roche) and 18E0- 05 (Roche)
Safety Alert for 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
Safety Alert for Trading name: Cobas 8000 Core Unit. Technical Name: Physiological Fluid Analyzer. ANVISA registration number: 10287410878. Class of risk: II. Model Affected: N / A. Serial numbers affected: 1137-08; 1149-06; 1150-01; 1162-10; 1163-02; 1211-02; 1211-03; 1212-10; 1216-19; 1220-17; 1221-07; 1287-10; 1290-02; 1296-09; 1339-03; 1339-04; 1365-01; 1365-02; 1365-09; 1374-06; 1374-10; 1476-04; 1476-05; 1478-08; 1480-09; 1480-10; 1481-07; 1482-03; 1485-06; 1486-02; 1492-03; 1492-04; 1492-05; 1495-09; 14A0-03; 14B8-07; 14B9-02; 14E2-06; 14E6-03; 14F1-13; 14F1-14; 14F1-20; 15G5-06; 15H3-02; 15H3-03; 15H3-04; 15H3-05; 15J5-09; 15J6-05; 15J6-07 ;. 15K4-08; 15K5-01; 15M4-01; 15M4-02; 15P0-01; 15P6-01; 15R9-07; 15R9-08; 15R9-10; 15S1-01; 15S3-02; 1618-07; 1618-08; 1628-02; 1640-06; 1653-03; 1656-06; 1657-02; 1657-03; 16S9-06; 16S9-07; 16U5-06; 16U5-07; 16U7-04; 16V8-04; 16V8-05; 16V8-06; 16V8-08; 16W0-10; 16X1-02; 16X1-03; 16X1-04; 16X1-05; 16Y7-01; 16Y7-02; 16Y7-03; 16Z1-09; 16Z7-08; 1776-05; 1776-07
Safety Alert for Cobas p 512 Pre-Analytical System, records 10287411043 and 10287410844, hazard class I, various series: 4700920; 4701020; 4701430; 4706631; 4706731; 4706831; 4706931; 4707031; 4707131; 4707231; 4707331; 4707431; 4707631; 4707831; 4708131; 4709431; 4709531; 4709631; 4709731; 4709831; 4709931; 4,710,231; 4,710,331; 4,714,441; 4,717,943; 4,719,644; 4,725,245; 4,725,345; 4,762,545; 4,727,745; 4,728,145; 4,728,245; 4,728,545; 4,730,345; 4,730,645; 4,732,745; 4,733,045; 4733245; 4,733,645; 4,733,745; 4,733,845; 4,734045; 4,735,345.
Safety Alert for Accu-Chek Inform II Base Unit and Handheld Base Unit, registry 10287410863, hazard class II, batches affected: 05802151 to 05205301 and 05809021 to 05205311.
Safety Alert for Bulk Loader (BLM), integral module of the Cobas p 512/612; Registration 10287411043; Hazard Class I, Serial Number: 7501721; 7501821; 7501921; 7502021.
Safety Alert for cobas b 123 Sensor Cartridge BG / ISE / GLU / LAC, an integral part of the COBAS B 123 POC System equipment (Record 10287410948) - Affected Lots Distributed in Brazil: 21552191/21552491/21552591/21552692
Safety Alert for Reflotron Uric Acid, Record: 10287410183, Lots: 20750002, 21149403, 21836402, 21625703, 21506202, 22222403, 22311502, 22500902, 22618503, 22915302, 23179404, 23336508
Safety Alert for Cobas b 123 Fluid Pack 200 and Cobas b 123 Fluid Pack 400, Registration No. 10287410927; Cobas b 123 Fluid Pack COOX 200, Cobas b 123 Fluid Pack COOX 400 and Cobas b 123 Fluid Pack COOX 700, Registration No. 10287410931. Lots involved Annex 1
Safety Alert for NHL, Ammonia - Registry 10287410128; NH3L - Registration 10287410768; GLDH-Glutamate Dehydrogenase - Registration 10287410752; CKMBL CK MB C111 Registration - 10287410673; CKMBL, Creatinine Kinase-MB - Registration 10287410530; CK-MB - Registration 10287410214; ASTLP, Aspartate aminotransferases acc. IFCC with pyroxidal phosphate activation - Record 10287410571; ASTL, Aspartate Aminotransferase acc. IFCC without pyroxidal phosphate activation - Record 10287410316; AST (ASAT / GOT) IFCC - Registration 10287410203; AST (ASAT / GOT) IFCC (SYS) - Registration 10287410258; ALTL, Alanine Aminotransferase acc. IFCC without phosphate activation - Record 10287410315; ALT (ALAT / GPT) IFCC (SYS) - Registration 10287410265; ALT (ALAT / GPT) IFCC - Registration 10287410184 - Lots and presentations - Annex I
Safety Alert for S2 FLUID PACK OMNI S, Registration: 10287410150, Lots: 21450781/21450887/21451391
Safety Alert for CREA plus, CREP2, LACT2, Lactate, GLU, TRIGL / TG, TRIGGS, TRIG / GB, CHOL / CHOL2, HDL-C plus 3rd generation / HDLC3, LDL_C plus 2nd generation / LDL_C. UA2 / UA plus - See Annex I (products and records). Potential customers affected - Annex II
Safety Alert for Accu-Chek® Spirit and Accu-Chek® Spirit Combo, Registration: 10287410883, Hazard Class III, Serial Numbers: SEE ANNEX.
Safety Alert for Insulin Infusion System, Registration: 10287410883, Serial Numbers - Annex I
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16 devices in the database
Trade Name: MagNA Pure 24 System. Technical Name: Instrument for analysis of nucleic acids. ANVIS...
Model / Serial
Trade name: Elecsys Vitamin D total II. Technical name: Vitamin D. ANVISA registration number: 10...
Model / Serial
Trading name: Cobas e801 Module. Technical name: Instrument for immunoassays. ANVISA registration...
Model / Serial
Trade name: Cobas 6500 - u 601 eu 701. Technical name: Instrument for urinalysis. ANVISA registra...
Model / Serial
Trading name: Cobas 8000 Core Unit. Technical Name: Physiological Fluid Analyzer. ANVISA registra...
Model / Serial
11 more
3 manufacturers with a similar name
Learn more about the data
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Roche Diagnóstica Brasil Ltda.; Roche Diagnostics GmBH; Unomedical
Manufacturer Parent Company (2017)
Roche Holding Ag
Source
ANVSANVISA
Roche Diagnóstica Brasil Ltda.; Roche Diagnostics GmBH.
Manufacturer Parent Company (2017)
Roche Holding Ag
Source
ANVSANVISA
Roche Diagnóstica Brasil Ltda.; Roche Diagnostics GmBH - Sandhofer Strasse 116 - 68305 - Alemanha
Manufacturer Parent Company (2017)
Roche Holding Ag
Source
ANVSANVISA
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