Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
The 4Kscore Test Recalled by BioReference Health, LLC Due to Mathematical modeling of the 4Kscore with and without...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact BioReference Health, LLC directly.
Affected Products
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).
Quantity: 1 system (3,196 tests)
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About BioReference Health, LLC
BioReference Health, LLC has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report