Z-1676-2023Class II

The 4Kscore Test is an in vitro serum or plasma test that combines the results of four immunoassays (Roche...

Name: Z-1676-2023 The 4Kscore Test is an in vitro serum or plasma test that combines the results of four immunoassays (Roche...
Creator: BioReference Health, LLC
Published: 2022-11-18
License: https://open.fda.gov/license/

BioReference Health, LLC / initiated 2022-11-18 / Open, Classified / root cause: software

FDA source

BioReference Health, LLC began a recall of 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... on 2022-11-18. FDA classified it as Class II and gives the reason as "SPM software anomalies that may lead to the generation of erroneous 4Kscore Test results". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1676-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-11-18
Posted: 2023-06-02
Recalling firm: BioReference Health, LLC
Product: 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 code: QRF Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer
Reason for recall: SPM software anomalies that may lead to the generation of erroneous 4Kscore Test results
Root cause tag: software
FDA root cause: Software Design Change
Action: Customers were notified via telephone between 11/18/22 and 12/31/22. In addition, the following information was provided within the corrected test results sent to customers: The 4Kscore result has been corrected to reflect the history of a prostatic nodule and/or the prior negative biopsy result, which was inaccurately posted into the algorithm, due to a bioinformatics error.
Quantity in commerce: 1 system (662 Patients test results affected)
Distribution: US Nationwide distribution in the state of New Jersey.
Product codes and lots: UDI: 00850038860004

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1676-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1676-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-06-14	2023-06-02

Product code QRF

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)