Device Type ID | 268 |
Device Name | Electrode, Ion Specific, Potassium |
Regulation Description | Potassium Test System. |
Regulation Medical Specialty | Clinical Chemistry |
Review Panel | Clinical Chemistry |
Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
Submission Type | 510(k) |
CFR Regulation Number | 862.1600 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | CEM |
GMP Exempt | No |
Summary MR | Ineligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Eligible For Accredited Persons Program |
Device Type ID | 268 |
Device | Electrode, Ion Specific, Potassium |
Product Code | CEM |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Potassium Test System. |
CFR Regulation Number | 862.1600 [🔎] |
Device Problems | |
---|---|
High Test Results | 31 |
Low Test Results | 23 |
Incorrect Or Inadequate Test Results | 13 |
Adverse Event Without Identified Device Or Use Problem | 6 |
Mechanical Problem | 4 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 3 |
Electrode | 3 |
Nozzle | 2 |
Probe | 2 |
Failure To Align | 1 |
Device Subassembly | 1 |
Cover | 1 |
Tube | 1 |
Spring | 1 |
False Device Output | 1 |
Device Issue | 1 |
Diaphragm | 1 |
Low Readings | 1 |
Cap | 1 |
Cups | 1 |
Seal | 1 |
Non Reproducible Results | 1 |
Total Device Problems | 100 |
Recalls | |||
---|---|---|---|
Manufacturer | Recall Class | Date Posted | |
1 | Abbott Laboratories | II | Jun-27-2015 |
2 | Inpeco S.A. | II | Nov-16-2016 |
3 | Roche Diagnostics Corporation | II | May-03-2018 |
4 | Siemens Healthcare Diagnostics, Inc. | II | Apr-07-2015 |