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).
Reported: December 20, 2023 Initiated: October 31, 2023 #Z-0516-2024
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.
Details
- Recalling Firm
- BioReference Health, LLC
- Units Affected
- 1 system (3,196 tests)
- Distribution
- US Nationwide distribution.
- Location
- Elmwood Park, NJ
Frequently Asked Questions
What product was recalled? ▼
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).. Recalled by BioReference Health, LLC. Units affected: 1 system (3,196 tests).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 20, 2023. Severity: Moderate. Recall number: Z-0516-2024.
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