Print version of this report
Type of Product Medical Device
TGA Recall Reference RC-2012-RN-00799-3
Product Name/Description ADVIA Centaur HIV 1/O/2 Enhanced (EHIV) reagent kit. An in vitro diagnostic medical device (IVD)

HIV 1/O/2 (EHIV) Readypack Lot Number Ending In: 093, 095, 097, 101, 103, 105, 107, 109

Multiple Kit Lots
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 6/08/2012
Responsible Entity Siemens Ltd Diagnostics Division
Reason/Issue There have been reports concerning quality control results outside of the expected ranges. Siemens has determined that this issue is due to a decrease in the onboard stability of the EHV assay reagents. This issue will be identified by the quality control material.
Recall Action Recall for Product Correction
Recall Action Instructions Siemens is providing work around instructions for users to follow.
Contact Information 1800 310 300 - Siemens Technical Support Centre