BioReference Health, LLC: Medical Device Recall in 2023 - (Recall #: Z-0516-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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).

Product Classification:

Class II

Date Initiated: October 31, 2023

Date Posted: December 20, 2023

Recall Number: Z-0516-2024

Event ID: 93050

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.

Status: Ongoing

Product Quantity: 1 system (3,196 tests)

Code Information:

UDI-DI: 00850038860004

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated