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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