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.
FDA Recall Z-1676-2023 · Posted 2023-06-02
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Recalling FirmBioReference Health, LLC
Recall StatusOpen, Classified
Product CodeQRF
Date Initiated2022-11-18
Product Quantity1 system (662 Patients test results affected)
Reason for Recall
SPM software anomalies that may lead to the generation of erroneous 4Kscore Test results
Firm Action
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.
Root Cause
Software Design Change
Distribution Pattern
US Nationwide distribution in the state of New Jersey.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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