BioReference Health recalls The 4Kscore Test due to potential missing digital rectal exam (DRE) information in results, which is required for accurate prostate cancer screening.
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.
BioReference Health is recalling The 4K:score Test because it may not include required digital rectal exam (DRE) information, which is critical for accurate prostate cancer screening results. This could lead to incorrect health assessments if DRE data is missing.
The 4Kscore Test requires digital rectal exam (DRE) information to be accurate. Without this data, the test may provide incorrect prostate cancer risk assessments, potentially leading to missed diagnoses or unnecessary procedures.
Men who have had The 4Kscore Test performed for prostate cancer screening are likely affected. Those who received the test without DRE information are at higher risk of inaccurate results.
The 4Kscore Test is a serum or plasma test that combines four immunoassays. It was sold with a unique identifier UDI-DI: 00850038860004.
Verify if the test results include digital rectal exam (DRE) information, as this is required for accurate prostate cancer screening.
The 4Kscore Test requires digital rectal exam (DRE) information to be accurate. Without this data, the test may provide incorrect prostate cancer risk assessments.
Check if your test results include digital rectal exam (DRE) information. If missing, contact BioReference Health for guidance.
The recall record does not specify a fix or remedy for missing DRE information.
We’ve drafted a message you can send BioReference Health to request your refund or repair — edit it as you like.
Subject: Recall Z-0516-2024 — BioReference Health BioReference Health Hello, I own a BioReference Health that is covered by recall Z-0516-2024 from BioReference Health. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
