Medical device manufacturer, Abbott, issued a medical device safety alert concerning its ARCHITECT systems with software version 9.41 and earlier. The affected devices are identified as the following:
- ARCHITECT i1000SR (List Number: 1L86, 1L87),
- ARCHITECT i2000SR (List Number: 3M74)
- ARCHITECT i2000 (List Number: 1G17, 8C89)
- ARCHITECT c4000 (List Number: 2P24, 1P86, 1R24, 1R25)
- ARCHITECT c8000 (List Number: 1G06)
- ARCHITECT c16000 (List Number: 3L77)
Please refer to the Field Safety Notice (FSN) of the manufacturer about the serial number of affected devices.
The manufacturer has identified three potential performance issues for the ARCHITECT Software version 9.41 and earlier:
- Issue 1: When an Error Code 3382, ‘Unable to process test, internal wash pressure (x) error (y) pipettor’ occurs, the ARCHITECT c4000 and the ARCHITECT c16000 are incorrectly placed into a ‘Scheduled Pause’ status rather than a ‘Stopped’ status. As a result, the processing module continues to process tests after the hardware error is detected. This may cause incorrect results to be generated.
- Issue 2: When configuring a Calibrator Sample Volume on the Configure Assays screen, if the user selects multiple assays, the calibrator sample volume from one assay may be carried into the calibrator sample volume for another assay. Incorrect calibrator sample volumes have the potential to generate incorrect calibration curves which may lead to incorrect results and delay of results due to the need to reconfigure assay parameters.
- Issue 3: When performing a backup on the ARCHITECT while the iARM is replenishing the wash buffer at the same time, the iARM loses communication with the System Control Center. The loss of communication may cause the wash buffer container to overflow. This has the potential to lead to physical and chemical hazards.
The manufacturer is releasing ARCHITECT software versions 9.45 and 9.50 to correct these issues. Before the updated software is installed, affected users should follow the necessary actions required as listed in the FSN issued by the manufacturer.
According to the manufacturer, the affected devices are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 8 Oct 2021