System, Test, Immunological, Antigen, Tumor

Dimension Vista LOCI CA 15-3 Flex reagent cartridge. In Vitro Diagnostic for the quantitative measurement of CA 15-3.

Negative bias with patient samples. The mean patient sample bias range from -26% to -33%,potential risk of delay in appropriate treatment and management decisions.

IMMULITE /IMMULITE 1000 BR-MA (CA15-3)

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.

IMMULITE 2000/IMMULITE 2000 XPi BR-MA (CA15-3)

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.

Siemens Healthcare BR Assay for CA 27.29

Operating range of the ADVIA Centaur systems is 18C to 30C (64.4F to 86.0F), a change in room temperature may increase or decrease assay results, depending on the specific assay and ADVIA Centaur system used.

Siemens ADVIA Centaur BR Assay: Catalog Number:

BR Assay for CA 27.29 Calibration Interval Change due quality control (QC) results outside of the expected ranges.

AxSYM CA 15-3 Reagent Pack; list 03B42; 100 test pack; an in vitro diagnostic; Abbott Laboratories, Abbott Park, IL 60064

Failure of the AxSYM instrument to open (actuate) some reagent packs from certain lots. The defects can result in probe crashes if not detected prior to placement of the reagent kit on the AxYM instrument.

CA 15-3 Controls, list 9C08-10; an In Vitro diagnostic for use with the AxSYM or IMx CA 15-3 reagents, calibrators and instruments; each kit contains 2 bottles

The CA 15-3 Controls replicates out of range high resulting in invalid runs.

Abbott AxSYM CA 15-3 Master Calibrator Pack, list 3B42-30; the pack contains two 4-mL bottles, with Master Calibrator 1 having 0 U/mL and Master Calibrator 2 ha

The CA 15-3 Calibrators may cause depressed values for the CA 15-3 High Control and for patient specimens.

CA 15-3 Calibrators, list 9C08-01; the pack contains six 4-mL bottles of 115D8:DF3 reactive determinants prediluted in TRIS buffer with protein stabilizers to y

The CA 15-3 Calibrators may cause depressed values for the CA 15-3 High Control and for patient specimens.

IMx CA 15-3 Reagent Pack, list 6A75-22; this reagent pack contains one 4-mL bottle of Mode 1 Calibrator along with other reagents; Abbott Laboratories, Abbott P

The CA 15-3 Calibrators may cause depressed values for the CA 15-3 High Control and for patient specimens.