BioReference Health

2 recalls •

• Categories: Diagnostic Equipment

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).

Class I - Dangerous

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.

Oct 31, 2023 Diagnostic Equipment Nationwide View Details →

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.

Class I - Dangerous

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

Nov 18, 2022 Diagnostic Equipment Nationwide View Details →