Upon inpeco request, the pistons supplier provided a report with the problem analysis and root cause, that was then reviewed and acknowledged by inpeco.Some batches of the pistons have been treated with a grease not foreseen by design.The use of a wrong grease was due to an human error (supplier personnel error) during manufacturing process.The pistons with the wrong grease, depending of grease quantity and working condition, have a higher probability to behave closer to the acceleration boundary, and may lead to an activation of the gate not synchronized with the sample carrier passage.The pistons supplier informed inpeco that the correct production process has been restored: the wrong grease has been removed on every work place that produce the pistons, and working instructions has been updated to prevent re-occurrence of the problem.The pistons treated with the non-conforming grease have not been evaluated as defective, since they have just an higher probability to behave closer to the acceleration boundary: the gates equipped with these pistons work according to design specifications.For this reason, it is not required the replacement on the field of the gates with the non-conforming grease, and inpeco evaluated that a field safety corrective action is not needed.No injury to patient was reported from the customer.No other similar event that led to sample spillage was reported from the field.No further investigation is required.
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