FDA Recalls 4Kscore Prostate Cancer Diagnostic Test Over Model Concerns
BioReference Health is recalling the 4Kscore Test, a prostate cancer risk diagnostic test used nationwide. The recall follows mathematical modeling performed on over 3,000 specimens regarding digital rectal exam (DRE) information requirements.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This Class II medical device recall involves a diagnostic test where mathematical modeling revealed technical concerns. No illnesses or injuries have been reported. As a diagnostic tool for prostate cancer risk assessment, inaccurate results represent a potential risk-of-harm scenario where injury has not yet been reported.
Plain-English summary
The FDA is issuing a Class II recall for the 4Kscore Test, an in vitro serum or plasma test manufactured by BioReference Health, LLC. This test combines results from four immunoassays (Roche Elecsys total PSA, free PSA, intact PSA, and human kallikrein 2) along with patient age, previous biopsy history, and digital rectal exam (DRE) results to generate a prostate cancer risk score.
The recall was initiated following mathematical modeling of the 4Kscore test performed on over 3,000 specimens. This modeling examined the test's performance with and without DRE information, which is a required component of the 4Kscore Test.
The affected system represents 3,196 individual tests and has been distributed nationwide in the United States.
The recalled product
- 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…
- Manufacturer
- BioReference Health, LLC
- Category
- Medical Device — Diagnostic Test
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: 00850038860004
Distribution
Distributed nationwide across the United States.
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