| Device Type ID | 567 |
| Device Name | Station, Pipetting And Diluting, For Clinical Use |
| Regulation Description | Pipetting And Diluting System For Clinical 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 | 862.2750 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | JQW |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 567 |
| Device | Station, Pipetting And Diluting, For Clinical Use |
| Product Code | JQW |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Pipetting And Diluting System For Clinical Use. |
| CFR Regulation Number | 862.2750 [🔎] |
| Device Problems | |
|---|---|
Use Of Device Problem | 5 |
Device Handling Problem | 4 |
Device Maintenance Issue | 2 |
Misassembly During Maintenance / Repair | 2 |
Inadequate Service | 2 |
Material Integrity Problem | 2 |
Device Fell | 1 |
Contamination During Use | 1 |
Loss Of Data | 1 |
Fracture | 1 |
Misassembled During Installation | 1 |
Difficult To Open Or Close | 1 |
Appropriate Term/Code Not Available | 1 |
Component Falling | 1 |
Computer Software Problem | 1 |
Break | 1 |
Failure To Align | 1 |
| Total Device Problems | 28 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | BD Biosciences, Systems & Reagents | II | Jun-25-2015 |
| 2 | Beckman Coulter Inc. | II | Jun-26-2015 |
| 3 | Hologic, Inc | II | Oct-11-2018 |
| 4 | PerkinElmer, Inc | II | Dec-16-2016 |
| 5 | PerkinElmer, Inc | II | Dec-12-2016 |
| 6 | Perkinelmer Life Sciences, Inc. | III | Feb-27-2018 |
| 7 | Tecan US, Inc. | II | Oct-11-2018 |
| 8 | Tecan US, Inc. | II | Oct-29-2014 |