BioReference Health, LLC: 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).

Recall number

Z-0516-2024

Recalling firm

BioReference Health, LLC

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).

Status

Open, Classified

Initiated

2023-10-31

Posted

2023-12-08

Terminated

not on file

Reason

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.

Root cause

Device Design

Action

A notification letter dated 10/31/23 was sent to customers. As of the FDA approval of 4Kscore in December 2021, only results with a digital rectal examination (DRE) input of Nodule or No Nodule are considered as valid. Customers who received 4Kscore results without having DRE information inputted (e.g., no information entered for Nodule or No Nodule ) are advised that these results may have increased uncertainty, potentially resulting in erroneous decision interpretations, as DRE information is required for the interpretation recommendations contained in the PMA approved device labeling. The device has now been modified such that if the required DRE information is not provided (e.g., no information entered for Nodule or No Nodule ), then the blood sample will be frozen and stored at our laboratory for up to 60 days, and 4Kscore results will not be performed unless the required DRE information is provided within 60 days. As per the package insert, the DRE cannot be performed within 96 hours before sample collection, but it can be performed after phlebotomy, or in the preceding 12 months before testing. If it is more convenient to schedule the DRE in an office visit after the blood draw, blood samples will be frozen and stored at our laboratory for up to 60 days. The required DRE information can be provided to our customer service center within that me, and the sample will be tested once this information is received. No results will be reported if the input of Nodule or No Nodule information is not received by 60 days. If there are any questions, please feel free to reach out by telephone: 1-833-4KSCORE (1-883-457-2673), Fax: 201-663-4113, or email: 4kcustomerservice@bioreference.com. Thank you again for allowing BioReference Health to assist you in the care of your patients with potential prostate cancer. Please respond using the page following this letter, by fax 201-663-4113, or email: 4kcustomerservice@bioreference.com to confirm receipt of thi

Quantity

1 system (3,196 tests)

Distribution

US Nationwide distribution.

Lot, serial or model codes

UDI-DI: 00850038860004

510(k) numbers

not on file

PMA numbers

["P190022"]

Product code

QRF

Firm FEI

3003652672

Firm city

Elmwood Park

Firm state

NJ

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

Copy