Recall Z-0516-2024— BioReference Health, LLC
Class II · Ongoing
Class II FDA medical device recall by BioReference Health, LLC, initiated 2023-10-31. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- BioReference Health, LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-10-31
- Firm location
- Elmwood Park, NJ, United States
Product description
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 for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.