Reported Dec 20, 2023 · Ongoing
The 4Kscore Test, an in vitro serum or plasma test that combines the results of four immunoassays (Roche Elecsys total…
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, 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 patient s age, previous biopsy, and digital rectal exam (DRE)
- Lot codes and dates
- UDI-DI00850038860004
- Amount recalled
- 1 system (3,196 tests)
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new BioReference Health, LLC recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.