Roche Diagnostics Corp.
FDA adverse event reports naming Roche Diagnostics Corp. as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: ROCHE DIAGNOSTICS CORP..
- Total reports
- 3,581
- Deaths
- 11
- Injuries
- 1,058
- Malfunctions
- 2,499
Reports per year
Source: FDA adverse event reports by year received, 2000–2018. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Glucose Dehydrogenase, GlucoseLFR1,133
- Hexokinase, GlucoseCFR858
- System, Test, Blood Glucose, Over The CounterNBW593
- System, Multipurpose For In Vitro Coagulation StudiesJPA314
- Analyzer, Chemistry (Photometric, Discrete), For Clinical UseJJE251
- Glucose Oxidase, GlucoseCGA142
- Single Use Only Blood Lancet With An Integral Sharps Injury Prevention FeatureFMK141
- Test, Time, ProthrombinGJS52
- Immunoassay Method, Troponin SubunitMMI28
- Electrode, Ion Specific, PotassiumCEM24
Recent recalls
- 2009-09-16TerminatedProcess control
Roche ACCU-CHEK Performa blood glucose test strips, Roche Diagnostics, Indianapolis, IN. Test strips for quantitative blood glucose measurements in fresh capillary, arterial, or neonatal blood, as well as in heparin (lithium or sodium) or EDTA anticoagulated venous blood.
There may be a significant negative bias when testing neonate samples.
- 2009-09-16TerminatedProcess control
Roche ACCU-CHEK Performa blood glucose meters/kits, Roche Diagnostics, Indianapolis, IN. Test strips for quantitative blood glucose measurements in fresh capillary, arterial, or neonatal blood, as well as in heparin (lithium or sodium) or EDTA anticoagulated venous blood.
There may be a significant negative bias when testing neonate samples.
- 2009-09-10TerminatedPackaging process control
Roche/Hitachi Preciset TDM I, Roche Diagnostics, Indianapolis, IN; Catalog No. 03375790 190. Calibrator designed for the calibration of Roche assays for the quantitative determination of certain drugs concentrations in human serum and plasma.
The bottle caps may be more difficult to remove than usual, and minor injuries may be caused by the application of the force required to open the bottles.
- 2009-09-10TerminatedPackaging process control
Roche/Hitachi Preciset TDM II, Roche Diagnostics, Indianapolis, IN; Catalog No. 03375781 190. Calibrator designed for the calibration of Roche assays for the quantitative determination of certain drugs concentrations in human serum and plasma.
The bottle caps may be more difficult to remove than usual, and minor injuries may be caused by the application of the force required to open the bottles.
- 2009-08-11TerminatedOther
Roche ACCU-CHEK Softclix Lancing Device, Distributed by Roche Diagnostics, Indianapolis, IN. Models 3144844001 (10 lancets) and 3583031002 (17 lancets). The device is used to prick the finger and to obtain a drop of blood in preparation for diabetes/insulin level testing.
The lancet cap may be missing, which could result in an unintended lancet stick to the user.
- 2009-08-11TerminatedOther
Roche ACCU-Chek Active Meter Kit, Roche Diagnostics, Indianapolis, IN; REF 03184501001 includes the Roche ACCU-CHEK Softclix Lancing Device, Distributed by Roche Diagnostics, Indianapolis, IN. Model 3144844001 (10 lancets). The device is used to prick the finger and to obtain a drop of blood in preparation for diabetes/insulin level testing.
The lancet cap may be missing, which could result in an unintended lancet stick to the user.
- 2009-08-11TerminatedOther
Roche ACCU-Chek Voicemate Meter, Roche Diagnostics, Indianapolis, IN; REF 12030802001 includes the Roche ACCU-CHEK Softclix Lancing Device, Distributed by Roche Diagnostics, Indianapolis, IN. Model 3144844001 (10 lancets). The device is used to prick the finger and to obtain a drop of blood in preparation for diabetes/insulin level testing.
The lancet cap may be missing, which could result in an unintended lancet stick to the user.
- 2009-08-11TerminatedOther
Roche ACCU-Chek Aviva Meter Kit, Roche Diagnostics, Indianapolis, IN; REF 04893247001 includes the Roche ACCU-CHEK Softclix Lancing Device, Distributed by Roche Diagnostics, Indianapolis, IN. Model 3144844001 (10 lancets). The device is used to prick the finger and to obtain a drop of blood in preparation for diabetes/insulin level testing.
The lancet cap may be missing, which could result in an unintended lancet stick to the user.
- 2009-08-11TerminatedOther
Roche Coaguchex XS Systems for Patient Self-Testing, Roche Diagnostics, Indianapolis, IN; REF 04837738001 includes the Roche ACCU-CHEK Softclix Lancing Device, Distributed by Roche Diagnostics, Indianapolis, IN. Model 3144844001 (10 lancets). The device is used to prick the finger and to obtain a drop of blood in preparation for diabetes/insulin level testing.
The lancet cap may be missing, which could result in an unintended lancet stick to the user.
- 2009-08-11TerminatedOther
Roche ACCU-CHEK Compact Plus Meter Kit, Roche Diagnostics, Indianapolis, IN; REFS 03149137001, 05177294001 and 05079241001 include the Roche ACCU-CHEK Softclix Lancing Device, Distributed by Roche Diagnostics, Indianapolis, IN. Model 3583031002 (17 lancets). The device is used to prick the finger and to obtain a drop of blood in preparation for diabetes/insulin level testing.
The lancet cap may be missing, which could result in an unintended lancet stick to the user.
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