Medical device manufacturer, Beckman Coulter, has issued a medical device safety alert concerning its AutoMate 2500 Family.
The manufacturer has identified there is a potential that a component on the recapper Module did not have the required coating specified for that part.
The coating on the recapper component helps to both ensure the longevity of the part, and help the gripper to release the parafilm so it properly seals to the tube. If there is an uncoated component on customer's recapper, this could lead to tubes not being properly sealed.
The manufacturer has determined that this situation would be highly unlikely to occur and the test results are not affected.
The manufacturer will schedule a time to affected customer's sites and confirm whether the proper coating on the recapper component is present, and replace the component if necessary.
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 7 June 2017