FDA Device recall Z-0516-2024
The 4Kscore Test, an in vitro serum or plasma test that combines the results of four immunoassays (Roche Elecsys total PSA (prostate specif…
- FDA Device
- Class II
- ongoing
- Published 2023-12-20
On 2023-12-20 the FDA classified a Class II recall of The 4Kscore Test, an in vitro serum or plasma test that combines the results of four immunoassays (Roche Elecsys total PSA (prostate specif… by Bioreference Health, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0516-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-10-31 |
| Published | 2023-12-20 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Bioreference Health |
| Distribution | US |
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).
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.
Identifiers
| code_info | UDI-DI: 00850038860004 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0516-2024%22
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