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Medical Device Recall Notice: Change to BR Monitor (CA 15-3) upper reference limit (URL)

A message from Edwin S. Monuki, MD, PhD, Chair, Department of Pathology & Laboratory Medicine


Purpose:
To inform all physicians and clinics that Beckman Coulter sent out an Urgent Medical Device Recall dated Sept. 25, 2017 regarding BR Monitor (CA 15-3). Beckman has lowered the 95% upper reference limit from 31 U/mL to 23.5 U/mL.

BR Monitor (CA 15-3) values below the 95% URL for a healthy population do not necessarily indicate the absence of breast cancer. Results obtained with BR Monitor (CA 15-3) should not be interpreted as absolute evidence for the presence or absence of disease. CA 15-3 values obtained by different assays should not be directly compared. The BR Monitor (CA 15-3) is not recommended as a cancer screening test.

Risk to Health
The risk to health applies to all patients being monitored with the BR Monitor (CA15-3) test at UCI Medical Center Laboratories. Patients in non-remission may have results below 31 U/mL.

For any questions or concerns contact the UCI Medical Center Chemistry Laboratory. Beckman Coulter support may also be reached at 1-800-854-3633 or at www.beckmancoulter.com.

Sincerely,

Bridgit Crews, PhD
Director of Clinical Chemistry

Edwin Monuki, MD, PhD
Chair, Department of Pathology and Laboratory Medicine