| Device Type ID | 4962 |
| Device Name | Processor, Tissue, Automated |
| Regulation Description | Automated Tissue Processor. |
| Regulation Medical Specialty | Pathology |
| Review Panel | Pathology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 864.3875 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | IEO |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4962 |
| Device | Processor, Tissue, Automated |
| Product Code | IEO |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Automated Tissue Processor. |
| CFR Regulation Number | 864.3875 [🔎] |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 319 |
Improper Or Incorrect Procedure Or Method | 167 |
Use Of Device Problem | 25 |
Appropriate Term/Code Not Available | 23 |
Device Displays Incorrect Message | 14 |
Device Operates Differently Than Expected | 14 |
Failure To Cycle | 7 |
Human Factors Issue | 6 |
Mechanical Problem | 4 |
Device Issue | 3 |
Leak / Splash | 3 |
Programming Issue | 3 |
Device Operational Issue | 2 |
Application Program Problem: Parameter Calculation Error | 2 |
Valve, Directional | 2 |
Device Maintenance Issue | 2 |
Fluid Leak | 2 |
Missing Value Reason | 2 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 1 |
Insufficient Information | 1 |
Component Incompatible | 1 |
Installation-Related Problem | 1 |
Device Handling Problem | 1 |
Degraded | 1 |
Maintenance Does Not Comply To Manufacturers Recommendations | 1 |
Therapeutic Or Diagnostic Output Failure | 1 |
No Apparent Adverse Event | 1 |
Human-Device Interface Problem | 1 |
| Total Device Problems | 610 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Leica Microsystems, Inc. | II | Jul-03-2017 |
| 2 | Leica Microsystems, Inc. | II | Sep-22-2015 |
| 3 | Leica Microsystems, Inc. | III | Sep-17-2015 |