The 4Kscore Test — Class II medical device recall Z-0516-2024
Ongoing recall by BioReference Health, LLC, reported 2023-12-20, distributed nationwide. Mathematical modeling of the 4Kscore with and without DRE information was recently performed on over 3,000 spe
| Recall number | Z-0516-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | BioReference Health, LLC, Elmwood Park, NJ, United States |
| Recall initiated | 2023-10-31 |
| Classified | 2023-12-08 |
| Reported by FDA | 2023-12-20 |
| Distributed | Nationwide (US) |
| UPC / GTIN / UDI-DI | 00850038860004 |
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).
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0516-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.