AUTOMATED IMMUNOASSAY ANALYZER
This device is manufactured by ABBOTT LABORATORIES (IRVING IA/CC).
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2020 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2019 | Unintended Electrical Shock | 1 | Device |
| 2019 | Thermal Decomposition of Device | 1 | Device |
| 2019 | Smoking | 10 | Device |
| 2019 | Overheating of Device | 2 | Device |
| 2019 | Mechanical Problem | 2 | Device |
| 2019 | Low Test Results | 11 | Device |
| 2019 | Leak/Splash | 3 | Device |
| 2019 | Incorrect, Inadequate or Imprecise Result or Readings | 1 | Device |
| 2019 | Incorrect Measurement | 1 | Device |
| 2019 | High Test Results | 23 | Device |
| 2019 | Fluid/Blood Leak | 1 | Device |
| 2019 | Flare or Flash | 1 | Device |
| 2019 | Fire | 5 | Device |
| 2019 | False Positive Result | 45 | Device |
| 2019 | False Negative Result | 4 | Device |
| 2019 | Computer Software Problem | 1 | Device |
| 2019 | Chemical Problem | 1 | Device |
| 2019 | Appropriate Term/Code Not Available | 5 | Device |
| 2019 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2018 | Unintended Movement | 1 | Device |
| 2018 | Thermal Decomposition of Device | 9 | Device |
| 2018 | Sparking | 1 | Device |
| 2018 | Smoking | 15 | Device |
| 2018 | Overheating of Device | 1 | Device |
| 2018 | Noise, Audible | 1 | Device |
| 2018 | Low Test Results | 10 | Device |
| 2018 | Leak/Splash | 1 | Device |
| 2018 | Incorrect Or Inadequate Test Results | 3 | Device |
| 2018 | High Test Results | 25 | Device |
| 2018 | High Readings | 1 | Device |
| 2018 | Fire | 1 | Device |
| 2018 | False Positive Result | 21 | Device |
| 2018 | False Negative Result | 5 | Device |
| 2018 | Device Operates Differently Than Expected | 1 | Device |
| 2018 | Device Fell | 1 | Device |
| 2018 | Charred | 2 | Device |
| 2018 | Appropriate Term/Code Not Available | 1 | Device |
| 2018 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2017 | Unintended Movement | 2 | Device |
| 2017 | Thermal Decomposition of Device | 2 | Device |
| 2017 | Sparking | 3 | Device |
| 2017 | Smoking | 7 | Device |
| 2017 | Overheating of Device | 1 | Device |
| 2017 | Low Test Results | 13 | Device |
| 2017 | Leak/Splash | 1 | Device |
| 2017 | Incorrect Or Inadequate Test Results | 8 | Device |
| 2017 | Human-Device Interface Problem | 1 | Device |
| 2017 | High Test Results | 25 | Device |
| 2017 | Fluid/Blood Leak | 4 | Device |
| 2017 | False Positive Result | 22 | Device |
| 2017 | False Negative Result | 5 | Device |
| 2017 | Device Operates Differently Than Expected | 1 | Device |
| 2017 | Charred | 5 | Device |
| 2017 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2016 | Smoking | 7 | Device |
| 2016 | Low Test Results | 4 | Device |
| 2016 | Incorrect Or Inadequate Test Results | 2 | Device |
| 2016 | High Test Results | 7 | Device |
| 2016 | Fluid/Blood Leak | 7 | Device |
| 2016 | Fire | 2 | Device |
| 2016 | False Positive Result | 4 | Device |
| 2016 | False Negative Result | 4 | Device |
| 2016 | Electrical /Electronic Property Problem | 1 | Device |
| 2015 | Thermal Decomposition of Device | 1 | Device |
| 2015 | Smoking | 1 | Device |
| 2015 | Mechanical Jam | 1 | Device |
| 2015 | Low Test Results | 3 | Device |
| 2015 | Incorrect Or Inadequate Test Results | 1 | Device |
| 2015 | False Positive Result | 3 | Device |
| 2015 | False Negative Result | 2 | Device |
| 2014 | Smoking | 2 | Device |
| 2014 | Low Test Results | 3 | Device |
| 2014 | Incorrect Or Inadequate Test Results | 3 | Device |
| 2014 | Incorrect Measurement | 1 | Device |
| 2014 | Improper or Incorrect Procedure or Method | 1 | Device |
| 2014 | High Test Results | 15 | Device |
| 2014 | Fire | 2 | Device |
| 2014 | False Positive Result | 8 | Device |
| 2014 | False Negative Result | 6 | Device |
| 2014 | Device Operates Differently Than Expected | 1 | Device |
| 2014 | Chemical Spillage | 1 | Device |
| 2014 | Appropriate Term/Code Not Available | 1 | Device |
| 2014 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2013 | High Readings | 1 | Device |