BioReference Health, LLC recalls The 4Kscore Test, an in vitro serum or plasma test that combines the results of four immunoassays (Roche Elecsys total PSA (prostate…
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.
Read the official notice →- Date
- 2023-12-20
- Country
- United States
- Brand
- BioReference Health
- Product
- The 4Kscore Test, an in vitro serum or plasma test that combines the results of four immunoassays (Roche Elecsys total PSA (prostate…
- Classification
- Class II
- Units
- US Nationwide distribution.
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More BioReference Health recalls
- 2023-06-14
USBioReference Health, LLC recalls The 4Kscore Test is an in vitro serum or plasma test that combines the results of four immunoassays (Roche Elecsys total PSA (prostate…
SPM software anomalies that may lead to the generation of erroneous 4Kscore Test results
FDA · DeviceBioReference Health, LLCUS Nationwide distribution in the state of New Jersey.Official notice →
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