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BioReference Health, LLC
2 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for BioReference Health, LLC and translate it into plain English — free weekly digest, optional same-day alerts.
- 2023-12-20FDA-DeviceClass IIThe 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.
- 2023-06-14FDA-DeviceClass IIThe 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
SPM software anomalies that may lead to the generation of erroneous 4Kscore Test results
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