Print version of this report

Type of Product	Medical Device
TGA Recall Reference	RC-2012-RN-01179-1
Product Name/Description	Phenobarbitol Reagent (used with ADVIA Chemistry System). An in vitro diagnostic medical device (IVD) Phenobarbitol Reagent (PHNB_2) Catalogue Number: 10377505 Lot Numbers: 244574, 256536 ARTG Number: 176643 An in vitro diagnostic medical device (IVD)
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	28/11/2012
Responsible Entity	Siemens Ltd Diagnostics Division
Reason/Issue	Internal studies have indicated there is an error which may cause control values and/or patient values to be increased or decreased by as much as 30%.
Recall Action	Recall
Recall Action Instructions	Siemens Healthcare is asking customers to discontinue use and dispose the affected stock. A review of previously generated results should be undertaken at the discretion of the Laboratory Director.
Contact Information	1800 310 300 - Siemens Technical Support Centre