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Devices
Name
Classification
Manufacturer
Risk Class
Country
Source
Device Recall Roche Molecular Systems cobas 4800 System
Clinical Chemistry and Clinical Toxicology Devices
Roche Diagnostics Operations, Inc.
2
United States
Device Recall Cobas b 123 POC system
Clinical Chemistry and Clinical Toxicology Devices
Roche Diagnostics Operations, Inc.
2
United States
Roche COBAS INTEGRA c111
Clinical Chemistry and Clinical Toxicology Devices
Roche Diagnostics Operations, Inc.
1
United States
Insulin infusion pump (as part of the ACCUCHEK Aviva Combo system)
General Hospital and Personal Use Devices
Roche Diagnostics Operations, Inc.
2
United States
ACCUCHEK Compact Plus
Clinical Chemistry and Clinical Toxicology Devices
Roche Diagnostics Operations, Inc.
2
United States
ELECSYS CrossLaps/Serum Immunoassay
Clinical Chemistry and Clinical Toxicology Devices
Roche Diagnostics Operations, Inc.
1
United States
Roche cobas e 602 module
Clinical Chemistry and Clinical Toxicology Devices
Roche Diagnostics Operations, Inc.
1
United States
Device Recall TinaQuant (Latex) HS Test System (CReactive Protein (Latex) High Sensitive)
Immunology and Microbiology Devices
Roche Diagnostics Operations, Inc.
2
United States
Device Recall Roche cobas 6800/8800 system, Hepatitis Viral B DNA Detection
Immunology and Microbiology Devices
Roche Diagnostics Operations, Inc.
3
United States
Device Recall Roche cobas p312 preanalytical system
Clinical Chemistry and Clinical Toxicology Devices
Roche Diagnostics Operations, Inc.
1
United States
Device Recall Roche cobas p471 system
Clinical Chemistry and Clinical Toxicology Devices
Roche Diagnostics Operations, Inc.
1
United States
Device Recall Roche cobas p 512 PreAnalytical Instrument, calculator
Clinical Chemistry and Clinical Toxicology Devices
Roche Diagnostics Operations, Inc.
1
United States
Device Recall Roche cobas p 612 PreAnalytical Instrument, calculator
Clinical Chemistry and Clinical Toxicology Devices
Roche Diagnostics Operations, Inc.
1
United States
Device Recall Roche RSD 800 Sorting System, calculator
Clinical Chemistry and Clinical Toxicology Devices
Roche Diagnostics Operations, Inc.
1
United States
Device Recall Roche RSD 800A Aliquoting System, calculator
Clinical Chemistry and Clinical Toxicology Devices
Roche Diagnostics Operations, Inc.
1
United States
Device Recall Roche VS II Aliquoter System
Clinical Chemistry and Clinical Toxicology Devices
Roche Diagnostics Operations, Inc.
1
United States
Device Recall Roche COBAS p 501 PostAnalytical Unit
Clinical Chemistry and Clinical Toxicology Devices
Roche Diagnostics Operations, Inc.
1
United States
Device Recall Roche cobas p 701 PostAnalytical Unit
Clinical Chemistry and Clinical Toxicology Devices
Roche Diagnostics Operations, Inc.
1
United States
Device Recall Roche COBAS INTEGRA 800 /800 CTS Analyzer, Analyzer,
Clinical Chemistry and Clinical Toxicology Devices
Roche Diagnostics Operations, Inc.
1
United States
Device Recall Roche URISYS 2400 Urine Analyzer
Clinical Chemistry and Clinical Toxicology Devices
Roche Diagnostics Operations, Inc.
2
United States
Device Recall cobas MODULAR PREANALYTICS system
Clinical Chemistry and Clinical Toxicology Devices
Roche Diagnostics Operations, Inc.
1
United States
Device Recall cobas 8000 Modular Analyzer Series, Modular e602 Immunoassay Analyzer
Clinical Chemistry and Clinical Toxicology Devices
Roche Diagnostics Operations, Inc.
1
United States
Device Recall cobas 6000 Series system/Modular e601: Immunoassay Analyzer
Clinical Chemistry and Clinical Toxicology Devices
Roche Diagnostics Operations, Inc.
1
United States
Device Recall cobas e411 Immunoassay Analyzer
Clinical Chemistry and Clinical Toxicology Devices
Roche Diagnostics Operations, Inc.
1
United States
Device Recall Roche/Hitachi MODULAR E170 Analytics System
Clinical Chemistry and Clinical Toxicology Devices
Roche Diagnostics Operations, Inc.
1
United States
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