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

Recall date

November 18, 2022

Source

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

Recall number

Z-1676-2023

FDA classification

Class II

Brand / firm

BioReference Health, LLC

Sold / distributed

US Nationwide distribution in the state of New Jersey.

Why it was recalled

SPM software anomalies that may lead to the generation of erroneous 4Kscore Test results

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 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.