The 4Kscore Test is an in vitro serum or plasma test that… recallZ-1676-2023 · BioReference Health, LLC · initiated Nov 18, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from BioReference Health, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
SPM software anomalies that may lead to the generation of erroneous 4Kscore Test results
FDA root cause category: Software Design Change
What the company is doing
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.
Recall details
- Recall number
- Z-1676-2023
- Status
- Open, Classified
- Initiated by the company
- Nov 18, 2022
- Posted by the FDA
- Jun 2, 2023
- Recalling firm
- BioReference Health, LLC
- Quantity
- 1 system (662 Patients test results affected)
- Product code
- QRF
- FDA submissions
- P190022
- Distribution
- US Nationwide distribution in the state of New Jersey.
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.
Code information (models, lots, serial numbers)
UDI: 00850038860004
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- 4Kscore Test 1Bioreference Health, LLC · Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer2 recalls1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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