The 4Kscore Test is an in vitro serum or plasma test that combines… — Class II medical device recall Z-1676-2023
Ongoing recall by BioReference Health, LLC, reported 2023-06-14, distributed nationwide. SPM software anomalies that may lead to the generation of erroneous 4Kscore Test results
| Recall number | Z-1676-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | BioReference Health, LLC, Elmwood Park, NJ, United States |
| Recall initiated | 2022-11-18 |
| Classified | 2023-06-02 |
| Reported by FDA | 2023-06-14 |
| Distributed | Nationwide (US) |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00850038860004 |
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.
Reason for recall
SPM software anomalies that may lead to the generation of erroneous 4Kscore Test results
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.