Roche Diagnostics GmbH
454 devices · 13,991 adverse event reports · 3 deaths reported · 16 devices named in recalls
Counts reflect reports that name each device's exact identifier. Larger companies sell more devices, so totals should not be read as a safety ranking.
- IRON Gen.2 10059605190Photometric method, iron (non-heme)3 reports
- CHEMSTRIP 10 UA TEST STRIPS 11895354160DIAZONIUM COLORIMETRY, UROBILINOGEN (URINARY, NON-QUANT.)2 reports
- Chemstrip 7 Test Strips 11008552160DIAZONIUM COLORIMETRY, UROBILINOGEN (URINARY, NON-QUANT.)2 reports
- Accutrend Glucose Test Strips 11447475160GLUCOSE OXIDASE, GLUCOSE2 reports
- cobas® NHP Negative Control Kit 1.0ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS2 reports
- Roche 9180 Sodium electrode 03110419180ELECTRODE, ION SPECIFIC, SODIUM2 reports
- Elecsys FSH 11775863122RADIOIMMUNOASSAY, FOLLICLE-STIMULATING HORMONE2 reports
- CReactive Protein Latex) 20764930322SYSTEM, TEST, C-REACTIVE PROTEIN2 reports
- Elecsys DHEA-S 3000087122RADIOIMMUNOASSAY, DEHYDROEPIANDROSTERONE (FREE AND SULFATE)2 reports
- Potassium Electrode 21029355001ELECTRODE, ION SPECIFIC, POTASSIUM2 reports
- Bicarbonate liquid 3289923190ENZYMATIC, CARBON-DIOXIDE2 reports
- Tinaquant IgA Gen2 3507343190IGA, ANTIGEN, ANTISERUM, CONTROL2 reports
- Tinaquant IgG Gen2 3507432190IGG, ANTIGEN, ANTISERUM, CONTROL2 reports
- Alanine Aminotransferase acc. to IFCC with pyridoxal phosphate activation 4467388190NADH OXIDATION/NAD REDUCTION, ALT/SGPT2 reports
- Elecsys Troponin T 4491815190IMMUNOASSAY METHOD, TROPONIN SUBUNIT2 reports
- Elecsys ACTH Test System 3255751190RADIOIMMUNOASSAY, ACTH2 reports
- Cholesterol Gen.2 04718917190ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL2 reports
- Iron Gen.2 5169291190Photometric method, iron (non-heme)2 reports
- Tinaquant Ferritin Gen4 5172390190FERRITIN, ANTIGEN, ANTISERUM, CONTROL2 reports
- Tina-quant Antistreptolysin O 5219191190ANTISTREPTOLYSIN - TITER/STREPTOLYSIN O REAGENT2 reports
- Lactate Dehydrogenase acc. to IFCC ver.2 5401674190NAD REDUCTION/NADH OXIDATION, LACTATE DEHYDROGENASE2 reports
- Albumin BCP 5599261190ALPHA-1-ANTITRYPSIN, ANTIGEN, ANTISERUM, CONTROL2 reports
- Elecsys HE4 Assay 5950929190Test, epithelial ovarian tumor associated antigen (he4)2 reports
- Tinaquant Lipoprotein a Gen.2 5852633190LIPOPROTEIN, LOW-DENSITY, ANTIGEN, ANTISERUM, CONTROL2 reports
- ONLINE TDM Acetaminophen Gen2 6769942190COLORIMETRY, ACETAMINOPHEN2 reports
- Elecsys CEA Assay 4491777160SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN2 reports
- Elecsys PTH STAT Immunoassay 4892470160RADIOIMMUNOASSAY, PARATHYROID HORMONE2 reports
- Elecsys AFP 07026706190KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER2 reports
- Elecsys free PSA 07027320190Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions2 reports
- Elecsys Cortisol II 6687733160FLUOROMETRIC, CORTISOL2 reports
- Elecsys CA 125 II Assay 11776223161TEST, EPITHELIAL OVARIAN TUMOR-ASSOCIATED ANTIGEN (CA125)2 reports
- Valproic Acid 5108438190ENZYME IMMUNOASSAY, VALPROIC ACID2 reports
- ONLINE TDM Acetaminophen Gen.2 08056684190COLORIMETRY, ACETAMINOPHEN2 reports
- ONLINE DAT Benzodiazepines II 08056927190Enzyme immunoassay, benzodiazepine2 reports
- Ethanol Gen.2 08057630190ALCOHOL DEHYDROGENASE, SPECIFIC REAGENT FOR ETHANOL ENZYME METHOD2 reports
- Tina-quant Ferritin Gen.4 08057648190FERRITIN, ANTIGEN, ANTISERUM, CONTROL2 reports
- Gamma-Glutamyltransferase ver.2 Standardized against IFCC / Szasz 08057796190KINETIC METHOD, GAMMA-GLUTAMYL TRANSPEPTIDASE2 reports
- Tina-quant IgG Gen.2 08057915190IGG, ANTIGEN, ANTISERUM, CONTROL2 reports
- ONLINE TDM Amikacin 08105383190AMIKACIN SERUM ASSAY2 reports
- Tina-quant Apolipoprotein A-1 ver.2 08105448190ALPHA-1-LIPOPROTEIN, ANTIGEN, ANTISERUM, CONTROL2 reports
- Tina-quant Cystatin C Gen.2 08105596190TEST, CYSTATIN C2 reports
- Elecsys IGFBP-3 07574690190RADIOIMMUNOASSAY, HUMAN GROWTH HORMONE2 reports
- Elecsys Anti-HBs 08343594160Test, hepatitis b (b core, be antigen, be antibody, b core igm)2 reports
- Elecsys free PSA 03289788160Test,Prostate Specific Antigen,Free,(Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions2 reports
- ONLINE TDM Phenytoin 08445567190ENZYME IMMUNOASSAY, DIPHENYLHYDANTOIN2 reports
- Elecsys total PSA 08791716160Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer2 reports
- Elecsys BRAHMS PCT 08828644190Procalcitonin assay2 reports
- Elecsys HIV combi PT 08924180160Test, HIV detection2 reports
- Elecsys Beta-CrossLaps/serum 09005781190COLUMN CHROMATOGRAPHY & COLOR DEVELOPMENT, HYDROXYPROLINE2 reports
- Elecsys T3 09007725190RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE2 reports
- Elecsys AFP 09015124190KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER2 reports
- Elecsys Syphilis 09015051162Test, donor, syphilis, antigens, treponemal2 reports
- Elecsys HTLV-I/II 09015272162Serology tests used for infectious disease screening of blood and plasma donations2 reports
- Elecsys Anti-HBc II 09014926162Serology tests used for infectious disease screening of blood and plasma donations2 reports
- Elecsys proBNP II STAT Immunoassay 09315276160Test, natriuretic peptide2 reports
- Elecsys HBsAg II 08814856160Test, hepatitis b (b core, be antigen, be antibody, b core igm)2 reports
- Elecsys HCG+ beta 09744428190SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN2 reports
- Elecsys free PSA 09744908190PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS2 reports
- ONLINE TDM Methotrexate 09230785190Enzyme immunoassay, methotrexate2 reports
- navify POC Operations 10170280001Calculator/data processing module, for clinical use2 reports
- CHEMSTRIP MICRAL URINE TEST STRIPS 11544039160INDICATOR METHOD, PROTEIN OR ALBUMIN (URINARY, NON-QUANT.)1 report
- Accutrend Plus Cholesterol strips 05213312160Enzymatic Esterase--Oxidase, Cholesterol1 report
- CoaguChek XS Pro Kit 5530199160TEST, TIME, PROTHROMBIN1 report
- pH Electrode 3111717180ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH1 report
- cobas b 221 GLU/LAC Cassette 03260887184Acid, Lactic, Enzymatic Method1 report
- Roche 9180 Potassium electrode 03110338180ELECTRODE, ION SPECIFIC, POTASSIUM1 report
- Roche 9180 Chloride electrode 03110451180ELECTRODE, ION-SPECIFIC, CHLORIDE1 report
- Roche 9180 Lithium Electrode 3110664180FLAME PHOTOMETRY, LITHIUM1 report
- cobas b 123 <3> POC system 5122279001ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH1 report
- cobas b 123 Sensor Cartridge BG/ISE/GLU/LAC 05170478001Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph1 report
- Tinaquant 2Microglobulin 11660551216SYSTEM, TEST, BETA-2-MICROGLOBULIN IMMUNOLOGICAL1 report
- ISE Standard High 11183982216CALIBRATOR, MULTI-ANALYTE MIXTURE1 report
- Immunoglobulin M 20737771322METHOD, NEPHELOMETRIC, IMMUNOGLOBULINS (G, A, M)1 report
- Rheumatoid Factors II 20764574322SYSTEM, TEST, RHEUMATOID FACTOR1 report
- ISE Solution 2 20738069122CALIBRATOR, MULTI-ANALYTE MIXTURE1 report
- Valproic Acid 20737933322ENZYME IMMUNOASSAY, VALPROIC ACID1 report
- Tinaquant Haptoglobin ver2 3005593322HAPTOGLOBIN, ANTIGEN, ANTISERUM, CONTROL1 report
- Tinaquant Transferrin ver2 3015050122TRANSFERRIN, ANTIGEN, ANTISERUM, CONTROL1 report
- Elecsys HCG CalSet 3302652190CALIBRATOR, PRIMARY1 report
- Tinaquant IgM Gen2 3507190190IGM (MU CHAIN SPECIFIC), ANTIGEN, ANTISERUM, CONTROL1 report
- Tinaquant Myoglobin Gen2 4580010190MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL1 report
- Triglycerides 04657594190LIPASE HYDROLYSIS/GLYCEROL KINASE ENZYME, TRIGLYCERIDES1 report
- Total Protein Gen2 monocromatic 4657586190BIURET (COLORIMETRIC), TOTAL PROTEIN1 report
- CReactive Protein Gen3 4956842190SYSTEM, TEST, C-REACTIVE PROTEIN1 report
- alpha-Amylase EPS ver.2 5167027190CATALYTIC METHODS, AMYLASE1 report
- Lactate Dehydrogenase acc to IFCC ver2 5169330190NAD REDUCTION/NADH OXIDATION, LACTATE DEHYDROGENASE1 report
- CReactive Protein Gen3 5172373190SYSTEM, TEST, C-REACTIVE PROTEIN1 report
- Elecsys hGH 5390125190RADIOIMMUNOASSAY, HUMAN GROWTH HORMONE1 report
- Alanine Aminotransferase / Aspartate Aminotransferase acc. to IFCC with PYP 5531462190NADH OXIDATION/NAD REDUCTION, ALT/SGPT1 report
- Ethanol Gen2 5967104190NAD-NADH, SPECIFIC REAGENT FOR ALCOHOL ENZYME METHOD1 report
- Albumin BCP 5975573190BROMCRESOL PURPLE DYE-BINDING, ALBUMIN1 report
- Triglycerides/Glycerol Blanked 05976006190LIPASE HYDROLYSIS/GLYCEROL KINASE ENZYME, TRIGLYCERIDES1 report
- Tinaquant 1Antitrypsin ver2 5991978190ALPHA-1-ANTITRYPSIN, ANTIGEN, ANTISERUM, CONTROL1 report
- Bilirubin Total Gen3 5795648190DIAZO COLORIMETRY, BILIRUBIN1 report
- cobas p 501 post-analytical unit 05158494001Calculator/data processing module, for clinical use1 report
- cobas p 701 Post-Analytical Unit 05349966001Calculator/data processing module, for clinical use1 report
- Tinaquant Lipoprotein a Gen.2 5852625190LIPOPROTEIN, LOW-DENSITY, ANTIGEN, ANTISERUM, CONTROL1 report
- Tina-quant Cystatin C Gen.2 6600239190TEST, CYSTATIN C1 report
- Calibrator for automated systems USA standardized 10759350360CALIBRATOR, MULTI-ANALYTE MIXTURE1 report
- ONLINE TDM Carbamazepine Gen4 7258062190ENZYME IMMUNOASSAY, CARBAMAZEPINE1 report