Home › Bioreference Health, LLC › 4Kscore Test
4Kscore Test
Bioreference Health, LLC · Model 1 · UDI-DI 00850038860004
QRF
Prescription
0
510(k) clearances
371
Adverse events
2
Recalls
3
Facilities
Description
4Kscore Specimen Collection Kit
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-10-31 | BioReference Health, LLC | 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. |
| 2022-11-18 | BioReference Health, LLC | SPM software anomalies that may lead to the generation of erroneous 4Kscore Test results |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.