Medical device manufacturer, BioMérieux, has issued a medical device safety alert concerning its VIDAS 3 system [Catalogue number: 412590].
The manufacturer was informed that some customers experienced pipetting issue on the instrument VIDAS 3 ref. 412590 when they use tubes with an external diameter of around 12 mm. The issue is due to a collision between a small flat step at the top of the tip and the tube edges when the pipettor is going down to aspirate in the tube. The instrument identifies the problem and errors 0956 XAPU and/or 0502 (loading bay errors) happen. There is no risk to have an incorrect diagnostic because the error message will occur before having a diagnostic result.
The manufacturer advises users to stop using the tubes size of 12 mm and to use tubes with a larger diameter (13 and/or 16 mm as per User Manual) until corrective actions are implemented. The user manual will be updated based on the investigation results.
According to the local supplier, the affected products were distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 23 December 2013