Reported Jun 14, 2023 · Ongoing
The 4Kscore Test is an in vitro serum or plasma test that combines the results of four immunoassays (Roche Elecsys…
BioReference Health, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: BioReference Health, LLC · 481 Edward H Ross Dr · Elmwood Park, NJ · 07407-3118
Is this the product you have?
- 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 following informationa patients age, previous biopsy, and digital rectal exam (DRE). Patients file (sample type, prior biopsy status, DRE status and age) are uploaded to the Specimen Processing Module (SPM). The results from the four assays are exported automatically to Lab Manager Application (B2 LIS) which automatically triggers the 4Kscore calculation when values of the four analytes are available. The 4Kscore test results are determined automatically by the validated laboratory information system algorithm calculation software
- Lot codes and dates
- UDI00850038860004
- Amount recalled
- 1 system (662 Patients test results affected)
Where it was sold
- Nationwide
- NJ
Why it was recalled
SPM software anomalies that may lead to the generation of erroneous 4Kscore Test results
This product could cause temporary or reversible health problems — stop using it.
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