BioReference Health recalls 4Kscore Test due to software anomalies causing potential erroneous results. Affected units may need correction to ensure accurate prostate cancer screening.
SPM software anomalies that may lead to the generation of erroneous 4Kscore Test results
BioReference Health is recalling its 4K:score Test due to software issues that could produce incorrect results. This affects prostate cancer screening accuracy and requires immediate attention to avoid misdiagnosis.
The SPM software anomalies can cause the 4Kscore Test to generate incorrect results. This may lead to false positive or negative outcomes in prostate cancer screening, potentially affecting treatment decisions.
Patients using the 4Kscore Test for prostate cancer screening are affected. Those with recent test results may be at higher risk of inaccurate outcomes.
The 4Kscore Test is a blood test for prostate cancer screening. Check if you have the test results from BioReference Health with the UDI code 00850038860004.
Review your 4Kscore Test results to determine if they are from the affected version with UDI 00850:0038860004.
The recall applies to the 4Kscore Test results generated by the affected software. If your test used the UDI code 00850038860004, it may be affected.
The recall record does not specify a remedy for correcting results. Contact BioReference Health directly for assistance.
Check if your test has the UDI code 00850038860004. If so, review your results and contact BioReference Health for guidance.
We’ve drafted a message you can send BioReference Health to request your refund or repair — edit it as you like.
Subject: Recall Z-1676-2023 — BioReference Health BioReference Health Hello, I own a BioReference Health that is covered by recall Z-1676-2023 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.
