Clinical Diagnostic Solutions
FDA Regulatory Profile
Summary
- Total Recalls
- 7
- 510(k) Clearances
- 3
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1001-2020 | Class II | Medonic M-Series Hematology Analyzer M16S BD ABR US Product code: 1400075; OUS Product code 1400 | January 2, 2020 |
| Z-1436-2014 | Class II | Boule Con-Diff Tri-Level Multi-Parameter Assayed Hematology Control, used for in vitro diagnostic u | February 24, 2013 |
| Z-0191-2013 | Class III | Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor the perform | March 24, 2011 |
| Z-0190-2013 | Class III | Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor the perform | March 24, 2011 |
| Z-0189-2013 | Class III | Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor the perform | March 24, 2011 |
| Z-0193-2013 | Class III | Boule Con Diff US Tri Pack, 6 Vials. For in vitro diagnostic use as a control to monitor the perf | August 4, 2010 |
| Z-0194-2013 | Class III | Boule Con-Diff Hematology Control 9 vials. For in vitro diagnostic use as a control to monitor th | August 4, 2010 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K041130 | CDS HEMATOLOGY CALIBRATOR (CDS CAL) | June 10, 2004 |
| K024173 | CDS 3-PD HEMATOLOGY CONTROLS | January 14, 2003 |
| K993375 | CDS LTX CONTROL LATEX PARTICLE SUSPENSION AND PRIMER | December 20, 1999 |