Home / Brands / BioReference Health
BioReference Health Recalls
2 recalls on record · June 14, 2023 to December 20, 2023 · Medical Devices
December 20, 2023Medical DevicesFDA
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
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.
June 14, 2023Medical DevicesFDA
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
Hazard: SPM software anomalies that may lead to the generation of erroneous 4Kscore Test results