BioReference Health, LLC
BioReference Health, LLC appears in FDA public data with 2 recalls, 0 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0516-2024, Class II) was initiated on October 31, 2023.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 0
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0516-2024 | Class II | The 4Kscore Test, an in vitro serum or plasma test that combines the results of four immunoassays (R | October 31, 2023 |
| Z-1676-2023 | Class II | The 4Kscore Test is an in vitro serum or plasma test that combines the results of four immunoassays | November 18, 2022 |