Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer
FDA adverse event reports and recall history for multi-analyte test system with algorithmic analysis for detection of prostate cancer (product code QRF), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 371
- Deaths
- 0
- Injuries
- 0
- Malfunctions
- 371
Recent recalls
- 2023-12-08Open, ClassifiedDevice Design
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).
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.
- 2023-06-02Open, ClassifiedSoftware Design Change
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.
SPM software anomalies that may lead to the generation of erroneous 4Kscore Test results
Monitor multi-analyte test system with algorithmic analysis for detection of prostate cancer automatically
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