FOR THE DETERMINATION OF CARDIAC TROPONIN-I IN HUMAN SERUM OR PLASMA
This device is manufactured by ABBOTT LABORATORIES.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2019 | Low Test Results | 1 | Device |
| 2019 | High Test Results | 22 | Device |
| 2019 | False Positive Result | 15 | Device |
| 2019 | False Negative Result | 1 | Device |
| 2018 | Low Test Results | 1 | Device |
| 2018 | Incorrect Or Inadequate Test Results | 5 | Device |
| 2018 | High Test Results | 18 | Device |
| 2018 | High Readings | 2 | Device |
| 2018 | False Positive Result | 5 | Device |
| 2018 | False Negative Result | 1 | Device |
| 2017 | Incorrect Or Inadequate Test Results | 3 | Device |
| 2017 | High Test Results | 20 | Device |
| 2017 | False Positive Result | 5 | Device |
| 2017 | False Negative Result | 1 | Device |
| 2016 | Incorrect Or Inadequate Test Results | 3 | Device |
| 2016 | High Test Results | 24 | Device |
| 2016 | False Positive Result | 2 | Device |
| 2016 | False Negative Result | 2 | Device |
| 2015 | Incorrect Or Inadequate Test Results | 1 | Device |
| 2015 | False Positive Result | 1 | Device |
| 2014 | Incorrect, Inadequate or Imprecise Result or Readings | 1 | Device |
| 2014 | Incorrect Or Inadequate Test Results | 3 | Device |
| 2014 | Improper or Incorrect Procedure or Method | 1 | Device |
| 2014 | High Test Results | 35 | Device |
| 2014 | False Positive Result | 22 | Device |
| 2014 | False Negative Result | 1 | Device |
| 2013 | Low Test Results | 1 | Device |
| 2013 | High Test Results | 3 | Device |
| 2013 | False Positive Result | 4 | Device |