Z-0516-2024 Class II Ongoing
FDA device recall Z-0516-2024 was initiated by BioReference Health, LLC on October 31, 2023 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 1 system (3,196 tests).
Recall Details
- Product Type
- Devices
- Report Date
- December 20, 2023
- Initiation Date
- October 31, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 system (3,196 tests)
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.
Distribution Pattern
US Nationwide distribution.
Code Information
UDI-DI: 00850038860004