Diagnostic Test Recall: 4Kscore Test Software Anomalies May Produce Erroneous Results
BioReference Health is recalling the 4Kscore Test system due to software anomalies in its processing module that may generate erroneous diagnostic results. The recall affects 662 patient test results distributed in New Jersey.
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: FDA Class II recall of a diagnostic test where software anomalies may produce erroneous results. No illnesses, injuries, or deaths have been reported. This constitutes a risk-of-harm product category without documented patient harm, meeting the High severity threshold.
Plain-English summary
The 4Kscore Test is an in vitro diagnostic device that combines results from four immunoassays (total PSA, free PSA, intact PSA, and human kallikrein 2) into a numerical score to assess prostate cancer risk. The test incorporates the patient's age, previous biopsy status, and digital rectal exam findings.
BioReference Health, LLC is recalling the 4Kscore Test system due to software anomalies in the Specimen Processing Module that may lead to generation of erroneous 4Kscore Test results. The automated calculation and reporting of test scores has been affected by these software issues.
This recall affects 662 patient test results from the affected system, distributed in New Jersey. Patients who received 4Kscore Test results from the affected system should consult with their healthcare provider about the potential inaccuracy of their results and what steps may be needed for follow-up.
The recalled product
- Product
- The 4Kscore Test is 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…
- Manufacturer
- BioReference Health, LLC
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: 00850038860004
Distribution
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