Medical device manufacturer, Abbott, has issued a medical device safety alert concerning its Alinity i Processing Module [List number: 03R65, Serial numbers: Ai01001 to Ai01336].
The manufacturer has identified an issue with the Alinity i Bulk Solution Dispense Pumps (Part number A‐35001280‐01) resulting in pump failures. The issue is linked to the design of an internal seal within the pump that allows a small amount of leakage of bulk solution. The failure of the pump could result in unexpected instrument down time potentially causing a delay in generating results.
According to the manufacturer, the amount of the leakage does not impact the ability of the pump to accurately dispense bulk solutions, and the leakage is contained within the service‐only area of the instrument. Therefore, the issue does not pose a risk of incorrect results nor a risk of physical exposure to the operator.
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 Sep 2018