BioReference Health, LLC

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
0
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0516-2024Class IIThe 4Kscore Test, an in vitro serum or plasma test that combines the results of four immunoassays (ROctober 31, 2023
Z-1676-2023Class IIThe 4Kscore Test is an in vitro serum or plasma test that combines the results of four immunoassays November 18, 2022