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Immunochemical, Ceruloplasmin

FDA product code CHN · Class 2 · Immunology

5
Registered devices
2
Adverse events
6
Recalls
3
510(k) clearances

Devices with this code

Ceruloplasmin — Roche Diagnostics GmbHDimension Vista® Ceruloplasmin Flex® reagent cartridge — Siemens Healthcare Diagnostics Products GmbHCeruloplasmin — Roche Diagnostics GmbHTinaquant Ceruloplasmin — Roche Diagnostics GmbHCeruloplasmin — Roche Diagnostics GmbH

Recent recalls

DateFirmReason
2017-06-05CSL Behring GmbHSiemens Healthcare Diagnostics has confirmed a negative bias of approximately -20% for results obtained with N Antiserum to Human Ceruloplasmin when calibrating
2017-06-05CSL Behring GmbHSiemens Healthcare Diagnostics has confirmed a negative bias of approximately -20% for results obtained with N Antiserum to Human Ceruloplasmin when calibrating
2017-05-23Siemens Healthcare Diagnostics, Inc.Complaint of high amount of ceruloplasmin patient results below the reference range (< 20 mg/dL [0.2 g/L]. PROT1 CAL and corresponding PROT1 CON L, M, and H a
2017-05-23Siemens Healthcare Diagnostics, Inc.Complaint of high amount of ceruloplasmin patient results below the reference range (< 20 mg/dL [0.2 g/L]. PROT1 CAL and corresponding PROT1 CON L, M, and H a
2017-05-23Siemens Healthcare Diagnostics, Inc.Complaint of high amount of ceruloplasmin patient results below the reference range (< 20 mg/dL [0.2 g/L]. PROT1 CAL and corresponding PROT1 CON L, M, and H a
2017-05-23Siemens Healthcare Diagnostics, Inc.Complaint of high amount of ceruloplasmin patient results below the reference range (< 20 mg/dL [0.2 g/L]. PROT1 CAL and corresponding PROT1 CON L, M, and H a

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