Recall Atlas

BioReference Health recalls

2 official recalls and safety alerts involving BioReference Health since 2023-06, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with BioReference Health or the relevant agency.

  1. 2023-12-20
  2. US
    Drugs & medicalClass II

    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.

    FDA · DeviceBioReference Health, LLCUS Nationwide distribution.Official notice →
  3. 2023-06-14
  4. US
    Drugs & medicalClass II

    BioReference 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 →