Medical device manufacturer, Beckman Coulter, has issued a medical device safety alert concerning its Automate 2550 and 1250, Aliquotter Tip Present Sensor.
The manufacturer has identified a rare potential issue with the tip present sensor within the Robot of the Aliquoter module. There has been one report of a misaligned sensor in an AutoMate system, which resulted in the system processing samples without pipette tips. A small number of samples were subject to cross-contamination and were sent to the error rack prior to analysis. In this particular case, the system gave no external sign of a misaligned tip present sensor.
According to the manufacturer, there is no impact to the Sorter module associated with this issue. In the remote instance that a sensor is misaligned, and the system does not trigger the error message that a tip is not present, there is a remote chance of sample cross-contamination. As a precautionary measure, the manufacturer has instructed field service engineers to inspect the tip present sensor for misalignment at their next service visit. If the users suspect or observe unusual contamination of the tip carrier arm while performing daily maintenance, as described in the Instructions for Use, they are recommended to contact the local supplier and discontinue use of the Aliquotter module.
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 31 January 2018