Company: BioReference Health, LLC
Date of Enforcement Report: 06/02/2023
Class II
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 patient’s age, previous biopsy, and digital rectal exam (DRE). Patient’s 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.
Recall Number
Z-1676-2023
REASON:
SPM software anomalies that may lead to the generation of erroneous 4Kscore Test results
RECALLING FIRM/MANUFACTURER:
BioReference Health, LLC
VOLUME OF PRODUCT IN COMMERCE:
1 system (662 Patients test results affected)
DISTRIBUTION:
US Nationwide distribution in the state of New Jersey.
