BioReference Health, LLC 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 th Recall
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According to the U.S. Food and Drug Administration (FDA)
Product
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 th
Brand
BioReference Health, LLC
Lot Codes / Batch Numbers
UDI: 00850038860004
Products Sold
UDI: 00850038860004
BioReference Health, LLC is recalling The 4Kscore Test is an in vitro serum or plasma test that combines the results of four immunoassays due to SPM software anomalies that may lead to the generation of erroneous 4Kscore Test results. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
SPM software anomalies that may lead to the generation of erroneous 4Kscore Test results
Recommended Action
Per FDA guidance
Customers were notified via telephone between 11/18/22 and 12/31/22. In addition, the following information was provided within the corrected test results sent to customers: The 4Kscore result has been corrected to reflect the history of a prostatic nodule and/or the prior negative biopsy result, which was inaccurately posted into the algorithm, due to a bioinformatics error.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026