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BioReference Health, LLC recalls The 4Kscore Test, an in vitro serum or plasma test that combines the results of four immunoassays (Roche Elecsys total P
Recalled December 20, 2023 · FDA recall Z-0516-2024 · BioReference Health
Hazard
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. · FDA Class II
Units
1 system (3,196 tests)
Sold at
US Nationwide distribution.
Description
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.
Product
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).
Manufacturer(s)
BioReference Health, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →