Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
The 4Kscore Test is an in vitro serum or plasma Recalled by BioReference Health, LLC Due to SPM software anomalies that may lead to the...
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 is 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 patients age, previous biopsy, and digital rectal exam (DRE). Patients file (sample type, prior biopsy status, DRE status and age) are uploaded to the Specimen Processing Module (SPM). The results from the four assays are exported automatically to Lab Manager Application (B2 LIS) which automatically triggers the 4Kscore calculation when values of the four analytes are available. The 4Kscore test results are determined automatically by the validated laboratory information system algorithm calculation software.
Quantity: 1 system (662 Patients test results affected)
Why Was This Recalled?
SPM software anomalies that may lead to the generation of erroneous 4Kscore Test results
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