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BioReference Health, LLC recalls The 4Kscore Test is an in vitro serum or plasma test that combines the results of four immunoassays (Roche Elecsys total
Recalled June 14, 2023 · FDA recall Z-1676-2023 · BioReference Health
Hazard
SPM software anomalies that may lead to the generation of erroneous 4Kscore Test results · FDA Class II
Units
1 system (662 Patients test results affected)
Sold at
US Nationwide distribution in the state of New Jersey.
Description
SPM software anomalies that may lead to the generation of erroneous 4Kscore Test results
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 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.
Manufacturer(s)
BioReference Health, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →