Recall Z-1676-2023— BioReference Health, LLC
Class II · Ongoing
Class II FDA medical device recall by BioReference Health, LLC, initiated 2022-11-18. FDA's recall record names no specific 510(k) clearance for this event. 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.
- Recalling firm
- BioReference Health, LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-11-18
- Firm location
- Elmwood Park, NJ, United States
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.