| Device Type ID | 2320 |
| Device Name | Counter, Differential Cell |
| Regulation Description | Automated Differential Cell Counter. |
| Regulation Medical Specialty | Hematology |
| Review Panel | Hematology |
| Premarket Review | Center For Biologics Evaluation & Research (CBER) |
| Submission Type | 510(k) |
| CFR Regulation Number | 864.5220 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | GKZ |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 2320 |
| Device | Counter, Differential Cell |
| Product Code | GKZ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Automated Differential Cell Counter. |
| CFR Regulation Number | 864.5220 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ABBOTT | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ABBOTT LABORATORIES | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BECKMAN COULTER | ||
SE - WITH LIMITATIONS | 1 | |
SUBSTANTIALLY EQUIVALENT | 2 | |
BECKMAN COULTER, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
HORIBA ABX SAS | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
SIEMENS HEALTHCARE DIAGNOSTICS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SYSMEX | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
SYSMEX CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
| Device Problems | |
|---|---|
Fluid Leak | 974 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 556 |
Low Test Results | 531 |
Leak / Splash | 258 |
Output Problem | 206 |
Pressure Problem | 107 |
Incorrect Or Inadequate Test Results | 75 |
High Test Results | 75 |
Adverse Event Without Identified Device Or Use Problem | 71 |
Device Displays Incorrect Message | 32 |
Missing Test Results | 26 |
Device Operates Differently Than Expected | 23 |
Smoking | 22 |
Device Handling Problem | 19 |
Mechanical Problem | 18 |
Device Operational Issue | 18 |
Thermal Decomposition Of Device | 17 |
Fire | 11 |
Improper Device Output | 11 |
Charred | 10 |
Insufficient Information | 9 |
Complete Blockage | 8 |
Device Issue | 8 |
Electrical /Electronic Property Problem | 8 |
Use Of Device Problem | 6 |
Patient Data Problem | 6 |
Air Leak | 6 |
Electrical Shorting | 6 |
Computer Software Problem | 6 |
Contamination During Use | 5 |
Improper Or Incorrect Procedure Or Method | 5 |
Data Problem | 5 |
Output Below Specifications | 4 |
Overheating Of Device | 4 |
Probe | 3 |
Aspiration Issue | 3 |
Tube | 3 |
Output Above Specifications | 3 |
Maintenance Does Not Comply To Manufacturers Recommendations | 3 |
Low Readings | 3 |
False Positive Result | 3 |
Human-Device Interface Problem | 2 |
Device Ingredient Or Reagent Problem | 2 |
Defective Component | 2 |
Device Contamination With Body Fluid | 2 |
Obstruction Of Flow | 2 |
Appropriate Term/Code Not Available | 2 |
Perivalvular Leak | 2 |
High Readings | 2 |
Circuit Failure | 2 |
Inadequate Or Insufficient Training | 2 |
Device Maintenance Issue | 2 |
Partial Blockage | 1 |
Fail-Safe Design Failure | 1 |
Device Contamination With Chemical Or Other Material | 1 |
Optical Problem | 1 |
Loss Of Power | 1 |
Application Program Problem: Medication Error | 1 |
Application Program Problem | 1 |
Installation-Related Problem | 1 |
Laser | 1 |
Display Or Visual Feedback Problem | 1 |
Split | 1 |
Blocked Connection | 1 |
No Device Output | 1 |
Temperature Problem | 1 |
Disconnection | 1 |
Kinked | 1 |
Loose Or Intermittent Connection | 1 |
Positioning Problem | 1 |
Sharp Edges | 1 |
Explosion | 1 |
Difficult To Open Or Close | 1 |
Physical Property Issue | 1 |
No Apparent Adverse Event | 1 |
Failure To Deliver | 1 |
Incorrect Measurement | 1 |
Melted | 1 |
Display Difficult To Read | 1 |
Issue With Displayed Error Message | 1 |
False Reading From Device Non-Compliance | 1 |
Difficult To Remove | 1 |
Sparking | 1 |
| Total Device Problems | 3220 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Abbott Laboratories | II | Mar-29-2019 |
| 2 | Abbott Laboratories | II | Mar-09-2017 |
| 3 | Abbott Laboratories | II | Apr-19-2016 |
| 4 | BD Biosciences, Systems & Reagents | III | Jul-16-2015 |
| 5 | BD Biosciences, Systems & Reagents | III | Aug-14-2014 |
| 6 | Beckman Coulter Inc. | I | Nov-20-2018 |
| 7 | Beckman Coulter Inc. | II | Dec-13-2017 |
| 8 | Beckman Coulter Inc. | II | Sep-07-2017 |
| 9 | Beckman Coulter Inc. | II | Sep-01-2017 |
| 10 | Beckman Coulter Inc. | II | May-24-2017 |
| 11 | Beckman Coulter Inc. | II | Jan-11-2017 |
| 12 | Beckman Coulter Inc. | II | Sep-02-2016 |
| 13 | Beckman Coulter Inc. | II | Dec-16-2015 |
| 14 | Beckman Coulter Inc. | II | Jun-20-2014 |
| 15 | Becton, Dickinson And Company, BD Biosciences | III | Aug-09-2016 |
| 16 | Becton, Dickinson And Company, BD Biosciences | II | Jul-21-2016 |
| 17 | Becton, Dickinson And Company, BD Biosciences | II | Apr-26-2016 |
| 18 | Becton, Dickinson And Company, BD Biosciences | III | Sep-24-2015 |
| 19 | JAS Diagnostics Inc. | II | Jun-30-2017 |
| 20 | Jas Diagnostics/Drew Scientific | II | Apr-27-2016 |
| 21 | Siemens Healthcare Diagnostics, Inc. | II | Dec-08-2016 |
| 22 | Siemens Healthcare Diagnostics, Inc. | II | Apr-20-2016 |
| 23 | Sysmex America Inc | II | Apr-14-2017 |
| 24 | Sysmex Corporation | II | Jun-10-2016 |