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BioReference Health, LLC

BioReference Health, LLC Recalls

All product recalls associated with BioReference Health, LLC.

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Recall Summary

Total Recalls

Past Year

Class I (Serious)

Most Recent

Oct 2023

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–2 of 2 recalls

BioReference Health, LLC: The 4Kscore Test, an in vitro serum or plasma test that c...

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.

FDAOct 31, 2023Nationwide• BioReference Health, LLC

BioReference Health, LLC: The 4Kscore Test is an in vitro serum or plasma test that...

SPM software anomalies that may lead to the generation of erroneous 4Kscore Test results

FDANov 18, 2022Nationwide• BioReference Health, LLC