| Device Type ID | 551 |
| Device Name | Centrifuges (micro, Ultra, Refrigerated) For Clinical Use |
| Regulation Description | General Purpose Laboratory Equipment Labeled Or Promoted For A Specific Medical Use. |
| Regulation Medical Specialty | Clinical Chemistry |
| Review Panel | Clinical Chemistry |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 862.2050 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | JQC |
| GMP Exempt | Yes |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 551 |
| Device | Centrifuges (micro, Ultra, Refrigerated) For Clinical Use |
| Product Code | JQC |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | General Purpose Laboratory Equipment Labeled Or Promoted For A Specific Medical Use. |
| CFR Regulation Number | 862.2050 [🔎] |
| Device Problems | |
|---|---|
Break | 105 |
Thermal Decomposition Of Device | 82 |
Device Inoperable | 81 |
Device Operates Differently Than Expected | 69 |
Detachment Of Device Component | 45 |
Charred | 40 |
Power Cord | 36 |
Material Fragmentation | 34 |
Latch | 15 |
Melted | 14 |
Smoking | 14 |
Inadequate User Interface | 12 |
Circuit Board | 10 |
Function Lid | 9 |
Power Supply | 6 |
Mechanical Problem | 6 |
Failure To Align | 4 |
Device Emits Odor | 4 |
Motor | 4 |
Circuit Failure | 4 |
Improper Or Incorrect Procedure Or Method | 4 |
Defective Component | 4 |
Misconnection | 2 |
Failure To Service | 2 |
Device Stops Intermittently | 2 |
Fire | 2 |
Use Of Device Problem | 2 |
Difficult To Open Or Close | 2 |
Connector | 2 |
Component Falling | 1 |
Manufacturing, Packaging Or Shipping Problem | 1 |
Crack | 1 |
Plug | 1 |
Cover | 1 |
Heat Sink | 1 |
Leak / Splash | 1 |
Device Maintenance Issue | 1 |
Low Test Results | 1 |
Electrical Shorting | 1 |
Device Issue | 1 |
Fumes Or Vapors | 1 |
Separation Failure | 1 |
Hole In Material | 1 |
Concentrator | 1 |
Intermittent Continuity | 1 |
Electrical /Electronic Property Problem | 1 |
Delivered As Unsterile Product | 1 |
Device Displays Incorrect Message | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Fracture | 1 |
Communication Or Transmission Problem | 1 |
Cable | 1 |
Inappropriate Shock | 1 |
Device Contamination With Body Fluid | 1 |
Electronic Property Issue | 1 |
Material Integrity Problem | 1 |
| Total Device Problems | 643 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Beckman Coulter Inc. | II | Jul-23-2016 |
| 2 | Iris Diagnostics | II | Dec-23-2014 |
| 3 | LW Scientific, Inc. | II | Mar-23-2019 |
| 4 | Terumo BCT, Inc. | II | Nov-16-2017 |