데이터베이스 소개
국제 의료기기 데이터베이스 사용법
데이터 다운받기
FAQ
출처표기
Manufacturers
Roche Diagnóstica Brasil Ltda; Roche Diagnostics GmBH
제조사 모회사 (2017)
Roche Holding Ag
Source
ANVSANVISA
25 Events
Commercial name: cobas b 221 <6> equipped with AutoQC module. Technical name: Instrument for analysis of blood gases, ions or pH. ANVISA registration number: 10287410226. Class of risk: II. Affected model: cobas b 221 <6> equipped with AutoQC Module. Serial number affected: see Distribution map 의 안전성 경고
Commercial name: cobas c 501 module and cobas c 502 module. Technical name: Physiological Fluid Analyzer. ANVISA registration number: 10287410597 and 10287410878. Risk class: I and II. Affected Model:. Serial numbers affected: 4745914001, 5964067001 의 안전성 경고
Trade name: cobas and 602 modules, cobas and 601 and E170. Technical Name: Physiological Fluid Analyzer. ANVISA registration number: 10287410597; 10287410878; 10287410671; Risk class: I and II. Affected Model:. Serial numbers affected: 4745922001, 5990378001, 4998642001, 3617505001 의 안전성 경고
Commercial name: Cobas e 411 and Elecsys 2010 analyzer. Technical name: Biochemical Analyzer. ANVISA registration number: 10287410608. Risk class: I. Model affected: N / A. Serial numbers affected: Not applicable. 의 안전성 경고
Product name: cobas® MPX Technical name: HIV, HBV AND HCV VIRUS NUCLEIC ACID ANVISA registration number: 10287411182 Hazard class: IV Affected model: 96 tests Serial numbers affected: 191957/195775 의 안전성 경고
COBAS P 512 PRE-ANALYTICAL SYSTEM Technical name: Instrument for the preparation and processing of samples - preanalytical phase ANVISA registration number: 10287411162 Hazard class: I Serial numbers affected: 64002616; 64002716; 64002816; 64002916; 64003016; 64003116; 64007017 (Roche stock) 의 안전성 경고
Name of the product: cobas® connection modules (CCM) - OUTPUT UNIT, accessory of the products under registration 10287411162 (cobas p512 and p612) Technical name: SAMPLE PROCESSOR ACCESSORY FOR HEALTH DIAGNOSIS ANVISA registration number: 10287411162 Hazard class: I Numbers Affected series: 20496176 204C5683 204C5684 204C5691 204C5692 204C5693 204C5694 204C5695 204C5700 (Roche stock) 204C5701 (Roche stock) 204C5702 (Roche stock) 의 안전성 경고
Commercial name: cobas and 602 module - cobas 8000 Technical name: Physiological Fluid Analyzer ANVISA registration number: 10287410878 Hazard class: II 의 안전성 경고
Cobas® HIV-1 and HBV Technical Name: ANVISA Registration Number: Hazard Class: IV Model Affected: Registries: 10287411153 and 10287411154 Serial Numbers Affected: 1) cobas® HIV-1 Test (6979599190) Lot W11636 2 ) cobas® HBV Test (6979564190) Lot W14007 의 안전성 경고
Name of Elecsys TSH and Elecsys PTH (1-84) Technical Name: THYROID STIMULATING HORMONE (TSH) and INTACT CATHOLIC HORMONE (iPTH) ANVISA Registration Number: Hazard Class: II Model Affected: Serial Numbers Affected: 185522 의 안전성 경고
Gentamicin (Gentamicin) Technical Name: GENT2 ONLINE TDM GENTAMICIN ANVISA Registration Number: 10287410655 Hazard Class: II Affected Model: GENT2 Serial Numbers Affected: 11916601 의 안전성 경고
Name of the product: Elecsys® Anti-HAV Technical Name: HEPATITIS A VIRUS (HAV) ANVISA Registration Number: 10287410468 Hazard Class: III Affected Model: 12542601; 13676201; 15829301; 15829302; 16,602,101; 16602102; 17969201; 18108901; 18108902; 18383501; 18383502; 18554101; 18554102; 18771301; 18771302; 17415201; 17546301; 17546302; 17703001; 17843301. 의 안전성 경고
Commercial name: cobas b 123 <4> POC system Technical name: Analyzer For Ph and Gases Registration number ANVISA: 10287410948 Hazard class: I 의 안전성 경고
Commercial name: Cobas c 111 analyzer (with and without ISE) Technical name: Biochemical analyzer ANVISA registration number: 10287410612 Hazard class: I 의 안전성 경고
Product name: Tina-quant HbA1c Gen.2 Technical name: HEMOGLOBIN GLICED Registration number ANVISA: Hazard class: II Model affected: Serial numbers affected: Lots distributed in Brazil for Product 4528123190: 11642201; 12661801; 6,017,2801; 60450301; 60801901; 6,089,850; 61710701; 68050801; 69089201; 69127401; 69337401; 69655201; 69986701; 69989301. Lots distributed in Brazil for Product 5401640190: 11641901; 60224601; 60802301; 61061101; 61711001; 69128101; 69337901; 69655601. 의 안전성 경고
Commercial name: cobas b 123 <4> POC system Technical name: Analyzer For Ph and Gases Registration number ANVISA: 10287410948 Hazard class: I Model affected: cobas b 123 POC system with software system version 4.7 의 안전성 경고
Accu-Chek Connect Application Technical Name: Accu-Chek Connect Application Registration Number ANVISA: Risk Class: Affected Model: Version 1.2.0, 1.2.2 and 2.0.0 (iOS and Android) Serial Numbers Affected: Required update of Accu-Chek Connect Application 1.2.0, 1.2.2, 2.0.0 (iOS and Android) to ensure correct Correction Bolus suggestion. 의 안전성 경고
Trade name: PreciControl Varia Technical name: MULTI-PARAMETER CONTROLS OF ONE OR MORE CONCENTRATIONS - CLASS II Registration number ANVISA: 10287410955 Hazard class: II Model affected: Serial numbers affected: 18928501 의 안전성 경고
Multiplate® Analyzer Technical Name: Haemostasis Analyzer Registration Number ANVISA: 10287411001 Hazard Class: I Affected Model: Serial Numbers Affected: List of Serial Number Distributed in Brazil and Potentially Affected: 100120; 100296; 100933; 101328; 101340; 101342; 101430; 101438; 101439; 101527; 101567; 101612. 의 안전성 경고
Trade Name: ChoiceLine 10 Technical Name: URINE TEST TAPE ANVISA Registration Number: 10287410230 Hazard Class: II Model Affected: Serial Numbers Affected: ChoiceLine 10 lots in Brazil (distributed + stock): 11517901; 11517902; 20203401; 20203402; 20339301; 20339302; 22451002; 22933201; 22933202; 23203301; 23203302. 의 안전성 경고
Accu-Chek Connect Application (iOS) Technical Name: Accu-Chek Connect Application (iOS) Registration Number ANVISA: 10287411061 Hazard Class: Model Affected: Version 1.2.0 for iOS 의 안전성 경고
Rack Tray Technical name: Rack Tray, part of the equipment listed in the field action notification SBN-CPS-2016-013 ANVISA registration number: 3378900001 Hazard class: III 의 안전성 경고
Trade name: COAGUCHEK XS PT TESTSTRIPS 6 tests //. Technical name: SELF-TEST FOR COAGULATION PARAMETERS //. ANVISA registration number: 10287410553 //. Risk class: III (High Risk) //. Affected lots: 11911822; 20646321; 20335921; 23343322; 23194921; 23073621 의 안전성 경고
Trade Name: COBAS B 123 POC SYSTEM /// registration 10287410948 /// class I-low risk //// Lot-series 00200276 to 00200787 의 안전성 경고
Trade name: GENT2 ONLINE TDM GENTAMICIN (Products for in vitro diagnostic use) /// register 10287410655 /// risk class II (Products presenting medium risk to user or patient and low risk to public health) // Lot 11916601 (distributed 2 in São Paulo-SP and 1 in Porto Velho-RO). 의 안전성 경고
{{ $t('card.reduce') }}
{{ $tc('card.more', left) }}
데이터베이스에서 발견된 의료기기 1건 데이터베이스에서 발견된 의료기기 25 건
Commercial name: cobas b 221 <6> equipped with AutoQC module. Technical name: Instrument fo...
모델명 / 제조번호(시리얼번호)
Commercial name: cobas c 501 module and cobas c 502 module. Technical name: Physiological Fluid A...
모델명 / 제조번호(시리얼번호)
Trade name: cobas and 602 modules, cobas and 601 and E170. Technical Name: Physiological Fluid An...
모델명 / 제조번호(시리얼번호)
Commercial name: Cobas e 411 and Elecsys 2010 analyzer. Technical name: Biochemical Analyzer. ANV...
모델명 / 제조번호(시리얼번호)
Product name: cobas® MPX Technical name: HIV, HBV AND HCV VIRUS NUCLEIC ACID ANVISA registration ...
모델명 / 제조번호(시리얼번호)
하나 더 20 건 더
Language
English
Français
Español
한국어