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.
- COAGUCHEK XS PT TEST 6 STRIP 4625374160TEST, TIME, PROTHROMBIN3 deaths1,681 reports
- cobas c 501 Module 4745914001ANALYZER, CHEMISTRY, MICRO, FOR CLINICAL USE1,628 reports
- cobas e 411 Immunoassay Analyzer 04775201001ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE685 reports
- cobas 8000 c 702 Module 6473245001ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE620 reports
- cobas e 601 Immunoassay Analyzer 04745922001ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE607 reports
- CoaguChek XS PT strips 4625315160TEST, TIME, PROTHROMBIN604 reports
- cobas e 411 Immunoassay Analyzer 04775279001ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE533 reports
- cobas e 801 Immunoassay Analyzer 07682913001ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE1 recall417 reports
- cobas 8000 cobas ISE module 05964075001ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE419 reports
- cobas 8000 c 502 Module 5964067001ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE403 reports
- cobas e 801 Immunoassay analyzer 08454345001ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE1 recall295 reports
- cobas c 503 analytical unit 08463662001ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE333 reports
- cobas e 602 Immunoassay Analyzer 05990378001ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE297 reports
- CoaguChek XS Patient Self Testing Care Kit 03666794001Test, Time, Prothrombin212 reports
- cobas c 311 4826876001ANALYZER, CHEMISTRY, MICRO, FOR CLINICAL USE203 reports
- cobas 8000 c 701 Module 5641489001ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE195 reports
- cobas pro ISE analytical unit 08464537001ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE148 reports
- CoaguChek XS Patient Self Testing Care Kit 4837738001TEST, TIME, PROTHROMBIN134 reports
- Elecsys FT3 III 09005811190RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE134 reports
- cobas® infinity central lab 07154003001Calculator/data processing module, for clinical use2 recalls31 reports
- cobas c 513 clinical chemistry analyzer 07649142001ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE118 reports
- Elecsys TSH 08443432190RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE116 reports
- Elecsys FT3 III 07027362190RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE111 reports
- Elecsys HIV Duo 08836973190Test, HIV detection105 reports
- Elecsys Estradiol III 6656021190RADIOIMMUNOASSAY, ESTRADIOL101 reports
- Sodium electrode 10825468001ELECTRODE, ION SPECIFIC, SODIUM99 reports
- cobas c 303 analytical unit 09793194001ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE96 reports
- cobas b 221 <6> system 3337154001ELECTRODE, ION SPECIFIC, POTASSIUM1 recall43 reports
- Elecsys HBsAg II 08814848190Test, hepatitis b (b core, be antigen, be antibody, b core igm)93 reports
- Iron Gen.2 3183696122Photometric method, iron (non-heme)1 recall16 reports
- Elecsys Estradiol III 07027249190RADIOIMMUNOASSAY, ESTRADIOL61 reports
- Creatine Kinase 7190794190DIFFERENTIAL RATE KINETIC METHOD, CPK OR ISOENZYMES1 recall11 reports
- Elecsys HCG+beta 07251025190SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN58 reports
- Elecsys Troponin T Gen 5 08469890160IMMUNOASSAY METHOD, TROPONIN SUBUNIT58 reports
- cobas b 221 <4> system 3337138001ELECTRODE, ION SPECIFIC, POTASSIUM1 recall7 reports
- Elecsys TSH Assay 11731459122RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE55 reports
- Elecsys Troponin I STAT Immunoassay 5094798160IMMUNOASSAY METHOD, TROPONIN SUBUNIT1 recall3 reports
- Tina-quant D-Dimer 3001245322FIBRIN SPLIT PRODUCTS1 recall2 reports
- Elecsys Troponin I Immunoassay 5094810160IMMUNOASSAY METHOD, TROPONIN SUBUNIT1 recall2 reports
- cobas b 221 <2> system 3337111001ELECTRODE, ION SPECIFIC, POTASSIUM1 recall1 report
- cobas u pack 06334601001METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE)1 recall1 report
- Roche 9180 Electrolyte Analyzer 3157334001ELECTRODE, ION SPECIFIC, CALCIUM50 reports
- Homocysteine Enzymatic Assay 6542921190URINARY HOMOCYSTINE (NONQUANTITATIVE) TEST SYSTEM1 recall0 reports
- Tina-quant D-Dimer 08105618190FIBRIN SPLIT PRODUCTS1 recall0 reports
- cobas pro Sample Supply Unit 08464502001ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE1 recall0 reports
- cobas pro SSU 09205632001ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE1 recall0 reports
- Elecsys total PSA 08791732190Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer48 reports
- Accu-Chek Inform II Instrument with RF card 5060303001SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER46 reports
- Tinaquant Hemoglobin A1c III 5336163190ASSAY, GLYCOSYLATED HEMOGLOBIN45 reports
- Elecsys FT4 IV 09043284190RADIOIMMUNOASSAY, FREE THYROXINE45 reports
- Elecsys Anti-HCV II 08837058190Assay, enzyme linked immunosorbent, hepatitis c virus44 reports
- Elecsys CMV IgG 09118551190ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS43 reports
- Elecsys Toxo IgM 07028024190ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII42 reports
- Elecsys Vitamin D total III 09038086190SYSTEM, TEST, VITAMIN D42 reports
- Elecsys HCG Test System 3271749160SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN39 reports
- cobas c 703 analytical unit 09502971001Analyzer, chemistry (photometric, discrete), for clinical use37 reports
- Calcium Gen2 5061482190TITRIMETRIC WITH EDTA AND INDICATOR, CALCIUM36 reports
- Elecsys FT3 III 09005803190RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE35 reports
- Calcium Gen2 5168449190TITRIMETRIC WITH EDTA AND INDICATOR, CALCIUM34 reports
- Elecsys CA 199 Immunoassay 11776193122SYSTEM, TEST, CARBOHYDRATE ANTIGEN (CA19-9), FOR MONITORING AND MANAGEMENT OF PANCREATIC CANCER32 reports
- Elecsys CA 19-9 07027028190SYSTEM, TEST, CARBOHYDRATE ANTIGEN (CA19-9), FOR MONITORING AND MANAGEMENT OF PANCREATIC CANCER32 reports
- Elecsys HCG Test System 08890587190SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN32 reports
- cobas c 111 analyzer 4528778001ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE31 reports
- Elecsys Anti-TPO 07026935190SYSTEM, TEST, THYROID AUTOANTIBODY31 reports
- Elecsys Anti-TSHR 08496609190SYSTEM, TEST, THYROID AUTOANTIBODY31 reports
- Elecsys Anti-HCV II 08836981190Assay, enzyme linked immunosorbent, hepatitis c virus31 reports
- Glucose HK 4404483190HEXOKINASE, GLUCOSE30 reports
- Elecsys Toxo IgM 04618858190ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII29 reports
- cobas c 111 analyzer with ISE 04777433001ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE29 reports
- Elecsys Troponin T Gen 5 08469865160IMMUNOASSAY METHOD, TROPONIN SUBUNIT29 reports
- CoaguChek XS PT strips 7797826160TEST, TIME, PROTHROMBIN28 reports
- Tina-quant Hemoglobin A1cDx Gen.3 08056668190Hemoglobin A1c test system28 reports
- Tina-quant Lipoprotein (a) Gen.2 08106126190LIPOPROTEIN, LOW-DENSITY, ANTIGEN, ANTISERUM, CONTROL28 reports
- Elecsys Syphilis 09015051190ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM28 reports
- Creatinine plus ver2 5168589190ENZYMATIC METHOD, CREATININE27 reports
- cobas® infinity central lab 09180443001Calculator/data processing module, for clinical use27 reports
- Elecsys Anti-HCV II 07026889190ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS26 reports
- Sodium electrode 10825468001ELECTRODE, ION SPECIFIC, SODIUM26 reports
- Sodium Electrode 21029371001ELECTRODE, ION SPECIFIC, SODIUM25 reports
- Creatinine plus ver2 3263991190ENZYMATIC METHOD, CREATININE25 reports
- Elecsys TSH 07028091190RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE25 reports
- Elecsys free PSA 08828610190Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions25 reports
- CoaguChek Vantus System 07729952160Test, Time, Prothrombin24 reports
- Chemstrip 10 MD Test Strips 3260763160METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE)23 reports
- cobas 8000 Core Unit 05641446001ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE22 reports
- Elecsys Ferritin 07027273190Radioimmunoassay (two-site solid phase), ferritin22 reports
- Elecsys CMV IgM 07027133190ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS22 reports
- Elecsys Toxo IgG 07028008190ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII22 reports
- Tina-quant Hemoglobin A1cDx Gen.3 07559674190Hemoglobin A1c test system22 reports
- Elecsys PTH 07251068190RADIOIMMUNOASSAY, PARATHYROID HORMONE21 reports
- Elecsys Vitamin B12 II 07028121190RADIOASSAY, VITAMIN B1221 reports
- Elecsys Rubella IgG 07027770190ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA21 reports
- Alkaline phosphatase acc. to IFCC Gen.2 08056757190NITROPHENYLPHOSPHATE, ALKALINE PHOSPHATASE OR ISOENZYMES21 reports
- Calcium Gen.2 08057427190Titrimetric with EDTA and indicator, calcium21 reports
- Cholesterol 08057443190ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL21 reports
- Triglycerides 08058687190LIPASE HYDROLYSIS/GLYCEROL KINASE ENZYME, TRIGLYCERIDES21 reports
- Creatinine plus ver.2 08057524190ENZYMATIC METHOD, CREATININE20 reports
- Total Protein UrineCSF Gen3 3333825190TURBIDIMETRIC, TOTAL PROTEIN19 reports
- Glucose HK 08057800190HEXOKINASE, GLUCOSE19 reports
- Elecsys Testosterone II 08946370190RADIOIMMUNOASSAY, TESTOSTERONES AND DIHYDROTESTOSTERONE19 reports