Siemens Healthcare Diagnostics Inc.DHXClass II

System, Test, Carcinoembryonic Antigen

Siemens Healthcare Diagnostics Inc.'s record for this product code

MDR events72All time

Recalls2All time

510(k) clearances0All time

Recent MDR events

72 adverse event reports on file

Recalls

2 recall events for this product code

TerminatedMay 4, 2018
Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE assays, 3gAllergy Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12, and these assays are susceptible to interference from biotin.
View FDA record ↗
TerminatedMay 4, 2018
Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE assays, 3gAllergy Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12, and these assays are susceptible to interference from biotin.
View FDA record ↗

510(k) clearances

0 clearances for this product code

No 510(k) clearances on file for Siemens Healthcare Diagnostics Inc. under this product code.