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Devices
Name
Classification
Manufacturer
Risk Class
Country
Source
Device Recall Enzyme Immunoassay, Vancomycin
Clinical Chemistry and Clinical Toxicology Devices
Roche Diagnostics Operations, Inc.
2
United States
Device Recall Elecsys Estradiol Assay
Clinical Chemistry and Clinical Toxicology Devices
Roche Diagnostics Operations, Inc.
1
United States
Device Recall Elecsys Estradiol Assay
Clinical Chemistry and Clinical Toxicology Devices
Roche Diagnostics Operations, Inc.
1
United States
Device Recall cobas p 512 preanalytical system
Clinical Chemistry and Clinical Toxicology Devices
Roche Diagnostics Operations, Inc.
1
United States
Device Recall AccuChek Inform II Blood Glucose Monitoring System.
Clinical Chemistry and Clinical Toxicology Devices
Roche Diagnostics Operations, Inc.
2
United States
Device Recall Roche cobas b 123 POC system
Clinical Chemistry and Clinical Toxicology Devices
Roche Diagnostics Operations, Inc.
2
United States
Device Recall Roche cobas b 123 POC system
Clinical Chemistry and Clinical Toxicology Devices
Roche Diagnostics Operations, Inc.
2
United States
Device Recall S2 Fluid Pack as a part of the cobas b221 Roche OMNI S systems
Clinical Chemistry and Clinical Toxicology Devices
Roche Diagnostics Operations, Inc.
2
United States
Device Recall Uric Acid plus ver.2
Clinical Chemistry and Clinical Toxicology Devices
Roche Diagnostics Operations, Inc.
1
United States
Device Recall Triglycerides/ Glycerol Blanked
Clinical Chemistry and Clinical Toxicology Devices
Roche Diagnostics Operations, Inc.
1
United States
Device Recall Triglycerides
Clinical Chemistry and Clinical Toxicology Devices
Roche Diagnostics Operations, Inc.
1
United States
Device Recall Boehringer Mannheim Direct LDLCholesterol
Clinical Chemistry and Clinical Toxicology Devices
Roche Diagnostics Operations, Inc.
1
United States
Device Recall LDLCholesterol plus 2nd Generation
Clinical Chemistry and Clinical Toxicology Devices
Roche Diagnostics Operations, Inc.
1
United States
Device Recall Lactate Dehydrogenase IFCC
Clinical Chemistry and Clinical Toxicology Devices
Roche Diagnostics Operations, Inc.
2
United States
Device Recall HDLCholesterol,
Clinical Chemistry and Clinical Toxicology Devices
Roche Diagnostics Operations, Inc.
1
United States
Device Recall HDLCholesterol, no pretreatment
Clinical Chemistry and Clinical Toxicology Devices
Roche Diagnostics Operations, Inc.
1
United States
Device Recall Creatinine reagent
Clinical Chemistry and Clinical Toxicology Devices
Roche Diagnostics Operations, Inc.
2
United States
Device Recall Creatinine Plus
Clinical Chemistry and Clinical Toxicology Devices
Roche Diagnostics Operations, Inc.
1
United States
Device Recall Total Cholesterol Assay
Clinical Chemistry and Clinical Toxicology Devices
Roche Diagnostics Operations, Inc.
1
United States
Device Recall Boehringer Mannheim Cholesterol Assay
Clinical Chemistry and Clinical Toxicology Devices
Roche Diagnostics Operations, Inc.
1
United States
Device Recall Cobas Homocysteine Enzymatic Assay
Clinical Chemistry and Clinical Toxicology Devices
Roche Diagnostics Operations, Inc.
2
United States
Device Recall The Roche OMNI S Analyzer: cobas b 221, versions 5 and 6
Clinical Chemistry and Clinical Toxicology Devices
Roche Diagnostics Operations, Inc.
2
United States
Device Recall ACCUCHEK Tender II Infusion Set
General Hospital and Personal Use Devices
Roche Diagnostics Operations, Inc.
2
United States
Device Recall ACCUCHEK Tender II Infusion Set
General Hospital and Personal Use Devices
Roche Diagnostics Operations, Inc.
2
United States
Device Recall ACCUCHEK Tender II Infusion Set
General Hospital and Personal Use Devices
Roche Diagnostics Operations, Inc.
2
United States
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