The 4Kscore Test recall
The 4Kscore Test, an in vitro serum or plasma test that combines the results of four immunoassays (Roche Elecsys total PSA (prostate specific…
Why was The 4Kscore Test 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 00850038860004
- Product
- The 4Kscore Test, an in vitro serum or plasma test that combines the results of four immunoassays (Roche Elecsys total PSA (prostate specific…
- Recalling firm
- BioReference Health, LLC
- Quantity
- 1 system (3,196 tests)
- Distribution
- US Nationwide distribution.
- Recall date
- December 20, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)