FDA Enforcement
Class II
Ongoing
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).
Recall: Z-0516-2024
·
Reported December 20, 2023
Enforcement
- Recall Number
- Z-0516-2024
- Event ID
- 93050
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- BioReference Health, LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 20, 2023
- Initiation Date
- October 31, 2023
- Classification Date
- December 8, 2023
- Address
- 481 Edward H Ross Dr, N/A, Elmwood Park, NJ, 07407-3118, United States
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
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.
Code Info
UDI-DI: 00850038860004
Distribution
US Nationwide distribution.
Quantity
1 system (3,196 tests)