ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
This device is manufactured by BECKMAN COULTER.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Incorrect, Inadequate or Imprecise Result or Readings | 1 | Device |
| 2023 | Low Test Results | 3 | Device |
| 2022 | Low Test Results | 1 | Device |
| 2019 | Fluid/Blood Leak | 1 | Device |
| 2018 | Low Test Results | 2 | Device |
| 2018 | Incorrect Or Inadequate Test Results | 1 | Device |
| 2017 | Low Test Results | 1 | Device |
| 2017 | Incorrect, Inadequate or Imprecise Result or Readings | 2 | Device |
| 2017 | Incorrect Or Inadequate Test Results | 2 | Device |
| 2016 | Low Test Results | 4 | Device |
| 2016 | Incorrect, Inadequate or Imprecise Result or Readings | 9 | Device |
| 2016 | Incorrect Or Inadequate Test Results | 2 | Device |
| 2016 | High Test Results | 1 | Device |
| 2016 | Fluid/Blood Leak | 3 | Device |
| 2016 | Device Issue | 1 | Device |
| 2015 | Leak/Splash | 1 | Device |
| 2015 | Fluid/Blood Leak | 1 | Device |
| 2014 | Thermal Decomposition of Device | 1 | Device |
| 2014 | No Device Output | 1 | Device |
| 2014 | Low Test Results | 13 | Device |
| 2014 | Low Readings | 2 | Device |
| 2014 | Leak/Splash | 13 | Device |
| 2014 | Incorrect Or Inadequate Test Results | 5 | Device |
| 2014 | Hole In Material | 1 | Device |
| 2014 | High Test Results | 11 | Device |
| 2014 | Fluid/Blood Leak | 18 | Device |
| 2014 | False Positive Result | 1 | Device |
| 2014 | False Device Output | 1 | Device |
| 2014 | Failure to Calibrate | 1 | Device |
| 2014 | Device Slipped | 2 | Device |
| 2014 | Device Operates Differently Than Expected | 1 | Device |
| 2014 | Device Emits Odor | 1 | Device |
| 2014 | Device Displays Incorrect Message | 10 | Device |
| 2014 | Calibration Problem | 1 | Device |
| 2013 | Suction Problem | 1 | Device |
| 2013 | Low Test Results | 1 | Device |
| 2013 | Leak/Splash | 1 | Device |
| 2013 | Incorrect Or Inadequate Test Results | 2 | Device |
| 2013 | High Test Results | 4 | Device |
| 2013 | Fluid/Blood Leak | 4 | Device |
| 2013 | Device Operates Differently Than Expected | 2 | Device |
| 2013 | Device Displays Incorrect Message | 2 | Device |