# FDA recall Z-0516-2024

> **BioReference Health, LLC** · Class II · device recall initiated 2023-10-31.

## 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.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-0516-2024
- **Recalling firm:** BioReference Health, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-10-31
- **Report date:** 2023-12-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Elmwood Park, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0516-2024

## Citation

> AI Analytics. FDA recall Z-0516-2024. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-0516-2024. Source: US FDA. Licensed CC0.

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