Data / Medical devices / United States / BioReference Health, LLC
BioReference Health, LLC: FDA-registered device maker in Elmwood Park, NJ, United States, 1 PMA approval
BioReference Health, LLC is registered with the FDA (registration 3003652672) in Elmwood Park, NJ, United States. It lists 1 device type. The FDA files 1 PMA approval under its listings, the newest dated December 7, 2021. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003652672
- Address
- 481 Edward H. Ross Drive, Elmwood Park, NJ, United States, 07407
- Owner or operator
- OPKO Health, Inc. (10059750)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- January 13, 2022
- Registered through
- 2026
- Brand names listed
- 4Kscore Test
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer | QRF | 3 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| December 7, 2021 | P190022 | 4Kscore Test | QRF | 3 | July 25, 2025 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| October 31, 2023 | 93050 | Class II | Ongoing | 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 s | 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. | accessdata.fda.gov |
| November 18, 2022 | 92205 | Class II | Ongoing | 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 | SPM software anomalies that may lead to the generation of erroneous 4Kscore Test results | accessdata.fda.gov |
Updated July 25, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.