CGCClass I

Radioimmunoassay, Gastrin

Clinical Chemistry · 21 CFR 862.1325

MDR events3All time

Recalls2All time

Registered firms4Currently listed

510(k) clearances10All time

Recent MDR events

3 adverse event reports on file

Event type breakdown

Malfunction3

Most-reported manufacturers

Siemens Healthcare Diagnostics Products, Limited2 Siemens Healthcare Diagnostics Products, Ltd.1

Recalls

2 recall events for this product code

Siemens Healthcare Diagnostics, Inc.
TerminatedMay 4, 2018
IMMULITE /IMMULITE 1000 Gastrin
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.
Z-1680-2018 · View FDA record ↗
Siemens Healthcare Diagnostics, Inc.
TerminatedMay 4, 2018
IMMULITE 2000/IMMULITE 2000 XPi Gastrin
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.
Z-1681-2018 · View FDA record ↗

Registered firms

4 firms currently registered for this product code

510(k) clearances

10 clearances for this product code