Medical device manufacturer, Waters Corporation, has initiated a medical device field safety corrective action concerning various models of mass spectrometry instruments. The affected models can be identified as follows:-
Waters ACQUITY TQD; ACQUITY SQD; LCT Premier XE; Quattro Premier; Quattro Premier XE; Quattro micro; Xevo G2 Tof; Xevo TQ; Xevo TQD & ZQ 2000
The manufacturer initiated this voluntary medical device correction because there is a possibility that the ion block source heater may fail. In some instances, the failure could cause a short term loss of or variation in sensitivity that may subsequently lead to inaccurate data. The loss of or variation in sensitivity is most pronounced in assays with shorter dwell times (i.e. less than 100 ms) and may not always be detected by quality control and internal standard value monitoring. No adverse events have been reported as a result of this potential issue.
According to the manufacturer, the affected devices were distributed in Hong Kong.
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 24 October 2012