Medical device manufacturer, Ortho Clinical Diagnostics, has issued a medical device safety alert concerning its ORTHO VISION Analyzer for BioVue [Product Code: 6904557] and ORTHO VISION Max Analyzer for BioVue [Product Code: 6904576].
The manufacturer has reported that while the analyzer is in maintenance mode, a specific operator action (pressing the cancel button while in a maintenance task) may cause unexpected movement of the grip arm and pipettor. From the manufacturer’s assessment, the severity of the potential injury is limited to a cut or bruise. On review of e-Connectivity data the manufacturer has been able to verify a low likelihood due to rare instances of the cancel button being selected during the maintenance task.
The manufacturer has identified that the unintended grip arm or pipettor movement is due to an anomaly in the software code and it will address the software anomaly in a future version of software.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 21 Jun 2021