FDA Device recall Z-1676-2023
The 4Kscore Test is an in vitro serum or plasma test that combines the results of four immunoassays (Roche Elecsys total PSA (prostate spec…
- FDA Device
- Class II
- ongoing
- Published 2023-06-14
On 2023-06-14 the FDA classified a Class II 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 spec… by Bioreference Health, citing SPM software anomalies that may lead to the generation of erroneous 4Kscore Test results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1676-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-11-18 |
| Published | 2023-06-14 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Bioreference Health |
| Distribution | US |
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
SPM software anomalies that may lead to the generation of erroneous 4Kscore Test results
Identifiers
| code_info | UDI: 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-1676-2023%22
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