IMMUNOCHEMISTRY ANALYZER
This device is manufactured by ROCHE DIAGNOSTICS.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Output Problem | 1 | Device |
| 2024 | Non Reproducible Results | 1 | Device |
| 2024 | Incorrect, Inadequate or Imprecise Result or Readings | 1 | Device |
| 2024 | High Test Results | 2 | Device |
| 2023 | Output Problem | 2 | Device |
| 2023 | Non Reproducible Results | 12 | Device |
| 2023 | Mechanical Problem | 1 | Device |
| 2023 | Material Integrity Problem | 1 | Device |
| 2023 | Low Test Results | 16 | Device |
| 2023 | Insufficient Information | 1 | Device |
| 2023 | Incorrect, Inadequate or Imprecise Result or Readings | 5 | Device |
| 2023 | Incorrect Measurement | 2 | Device |
| 2023 | High Test Results | 8 | Device |
| 2022 | Chest Pain | 1 | Patient |
| 2022 | Output Problem | 1 | Device |
| 2022 | Optical Problem | 1 | Device |
| 2022 | Non Reproducible Results | 48 | Device |
| 2022 | Mechanics Altered | 1 | Device |
| 2022 | Mechanical Problem | 1 | Device |
| 2022 | Low Test Results | 32 | Device |
| 2022 | Labelling, Instructions for Use or Training Problem | 1 | Device |
| 2022 | Insufficient Information | 2 | Device |
| 2022 | Incorrect, Inadequate or Imprecise Result or Readings | 10 | Device |
| 2022 | Incorrect Measurement | 2 | Device |
| 2022 | High Test Results | 23 | Device |
| 2022 | Degraded | 1 | Device |
| 2022 | Contamination | 1 | Device |
| 2022 | Computer Software Problem | 1 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2021 | Non Reproducible Results | 1 | Device |
| 2021 | Low Test Results | 1 | Device |