PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: June 14, 2023 Initiated: November 18, 2022 #Z-1676-2023

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.

Reason for Recall

SPM software anomalies that may lead to the generation of erroneous 4Kscore Test results

Details

Recalling Firm
BioReference Health, LLC
Units Affected
1 system (662 Patients test results affected)
Distribution
US Nationwide distribution in the state of New Jersey.
Location
Elmwood Park, NJ

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by BioReference Health, LLC. Units affected: 1 system (662 Patients test results affected).
Why was this product recalled? ▼
SPM software anomalies that may lead to the generation of erroneous 4Kscore Test results
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 14, 2023. Severity: Moderate. Recall number: Z-1676-2023.

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