BioReference Health, LLC recalls The 4Kscore Test, an in vitro serum or plasma test that combines the results of four immunoassays (Roche Elecsys total…

Recall date

October 31, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0516-2024

FDA classification

Class II

Brand / firm

BioReference Health, LLC

Sold / distributed

US Nationwide distribution.

Why it was recalled

Mathematical modeling of the 4Kscore with and without DRE information was recently performed on over 3,000 specimens. DRE information is a required component of The 4Kscore Test.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

The 4Kscore Test, an in vitro serum or plasma test that combines the results of four immunoassays (Roche Elecsys total PSA (prostate specific antigen), Roche Elecsys free PSA, intact PSA, and human kallikrein 2) into a single numerical score that also incorporates the following information: a patient s age, previous biopsy, and digital rectal exam (DRE).