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Type of Product	Medical Device
TGA Recall Reference	RC-2012-RN-01068-1
Product Name/Description	Various mass spectrometers - Quattro micro, ACQUITY TQD, Quattro Premier XE, Xevo TQ; In vitro diagnostic medical devices (IVD's) Quattro micro Part:VB-QMicro Serial Numbers:QAA1167, QAA412, QAA742, QAA65, QAA765, QAA802 & QAA836 ACQUITY TQD Part:186003875 Serial Numbers:QBA470, QBB795, QBB924 & QBB928 Quattro Premier XE Part:186003250 Serial Numbers:VAB1000, VAB1215, VAB610, VAB844, VAB845 & WAB998 Xevo TQ Part:186004490 Serial Numbers: VBA626 & VBA744 ARTG Number: 201727
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	22/10/2012
Responsible Entity	Emergo Asia Pacific Pty Ltd T/a Emergo Australia
Reason/Issue	There is a possibility that the ion block source heater may fail. In some instances, the failure could cause short term loss or variation of sensitivity that may subsequently lead to inaccurate data. The loss of or variation in sensitivity is most pronounced in assays with shorter dwell times and may not always be detected by quality control and internal standard value monitoring.
Recall Action	Recall for Product Correction
Recall Action Instructions	Customers to contact their Waters field service engineer to order a replacement part (ion block source heater).
Contact Information	02 9006 1662 - Mike Skalsky