Bioreference Health recalls
Bioreference Health appears in 2 official U.S. recall notices indexed by RecallRadar, most recently on 2023-12-20.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 2 |
|---|---|
| Published | 2023-06-14 to 2023-12-20 |
| By agency | FDA Device (2) |
| By classification | Class II (2) |
| By status | ongoing (2) |
| Distribution named in notices | US |
Recalls
- The 4Kscore Test, an in vitro serum or plasma test that combines the results of four immunoassays (Roche Elecsys total PSA (prostate specif…
FDA Device · Class II · 2023-12-20 · Bioreference Health
Reason: 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. - The 4Kscore Test is an in vitro serum or plasma test that combines the results of four immunoassays (Roche Elecsys total PSA (prostate spec…
FDA Device · Class II · 2023-06-14 · Bioreference Health
Reason: SPM software anomalies that may lead to the generation of erroneous 4Kscore Test results