BioReference Health, LLC FDA Recalls

2 recalls on file across devices, 0 of them Class I and 2 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
The 4Kscore Test, an in vitro serum or plasma test that combines the results of four immunoassays (Roche Elecsys total PClass IIOct 31, 2023Mathematical modeling of the 4Kscore with and without DRE in	Mathematical modeling of the 4Kscore with and without DRE information was recently performed on over 3,000 spe	Class IIDevices	Oct 31, 2023
The 4Kscore Test is an in vitro serum or plasma test that combines the results of four immunoassays (Roche Elecsys totalClass IINov 18, 2022SPM software anomalies that may lead to the generation of er	SPM software anomalies that may lead to the generation of erroneous 4Kscore Test results	Class IIDevices	Nov 18, 2022