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Ceruloplasmin
Roche Diagnostics GmbH · Model 08105553190 · UDI-DI 07613336133613
CHN
Prescription
3
510(k) clearances
2
Adverse events
6
Recalls
5
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-06-05 | CSL Behring GmbH | Siemens Healthcare Diagnostics has confirmed a negative bias of approximately -20% for results obtained with N Antiserum to Human Ceruloplasmin when calibrating Ceruloplasmin with |
| 2017-06-05 | CSL Behring GmbH | Siemens Healthcare Diagnostics has confirmed a negative bias of approximately -20% for results obtained with N Antiserum to Human Ceruloplasmin when calibrating Ceruloplasmin with |
| 2017-05-23 | Siemens 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 are inaccurately assi |
| 2017-05-23 | Siemens 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 are inaccurately assi |
| 2017-05-23 | Siemens 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 are inaccurately assi |
| 2017-05-23 | Siemens 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 are inaccurately assi |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.