The 4Kscore Test is an in vitro serum or plasma test recall: Software Issue
The 4Kscore Test is 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 is an in vitro serum or plasma test recalled?
SPM software anomalies that may lead to the generation of erroneous 4Kscore Test results
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: 00850038860004
- 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…
- Recalling firm
- BioReference Health, LLC
- Quantity
- 1 system (662 Patients test results affected)
- Distribution
- US Nationwide distribution in the state of New Jersey.
- Recall date
- June 14, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)