BD Biosciences, Systems & Reagents
FDA Regulatory Profile
Summary
- Total Recalls
- 9
- 510(k) Clearances
- 0
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2090-2015 | Class III | BD Flow Cytometers; used on all BD FACSCount, BD FACSCalibur, BD FACSCanto, BD FACSCanto II, BD LSR | June 15, 2015 |
| Z-1375-2015 | Class II | CD123 (9F5) PE Catalog number 649453 Analyte Specific Reagent | March 23, 2015 |
| Z-1370-2015 | Class II | BD FACSCalibur; Catalog Numbers 342973, 342975, 34976 In vitro Diagnostics Use. | March 6, 2015 |
| Z-1000-2015 | Class II | CD8 (Leu-2a) PE (In vitro diagnostic), Catalog number 340046. Hematology: Single color direct imm | December 19, 2014 |
| Z-1002-2015 | Class II | Anti-Lambda APC-H7, Catalog Number 656157. Product Usage: Intended for in vitro flow cytometri | December 19, 2014 |
| Z-2233-2014 | Class III | BD Multi Check CD4 Low Control Catalog No. 340916 is intended as a complete process control for imm | July 18, 2014 |
| Z-1977-2014 | Class II | BD FACS Canto and associated Fluidics Cart Product Usage: Flow cytometer for use in In vitro Dia | June 6, 2014 |
| Z-1536-2014 | Class II | Anti EpCam PE - Analyte Specific Reagent. Anti-EpCAM is directed against human epithelial adhesio | April 4, 2014 |
| Z-2397-2012 | Class II | BD FACS 7-color Setup beads BD Biosciences, San Jose, CA 95131. BD FACS 7 color Setup Beads ar | June 29, 2012 |