BioReference Health, LLC: Medical Device Recall in 2023 - (Recall #: Z-1676-2023)

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 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 single numerical score that also incorporates the following information: a patients age, previous biopsy, and digital rectal exam (DRE). Patients file (sample type, prior biopsy status, DRE status and age) are uploaded to the Specimen Processing Module (SPM). The results from the four assays are exported automatically to Lab Manager Application (B2 LIS) which automatically triggers the 4Kscore calculation when values of the four analytes are available. The 4Kscore test results are determined automatically by the validated laboratory information system algorithm calculation software.

Product Classification:

Class II

Date Initiated: November 18, 2022

Date Posted: June 14, 2023

Recall Number: Z-1676-2023

Event ID: 92205

Reason for Recall:

SPM software anomalies that may lead to the generation of erroneous 4Kscore Test results

Status: Ongoing

Product Quantity: 1 system (662 Patients test results affected)

Code Information:

UDI: 00850038860004

Distribution Pattern:

US Nationwide distribution in the state of New Jersey.

Voluntary or Mandated:

Voluntary: Firm initiated