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Type of Product Medical Device
TGA Recall Reference RC-2012-RN-00765-3
Product Name/Description ADVIA Centaur Multi-Diluent 1 supplied with ADVIA Centaur BNP kit and ADVIA Centaur TSH-3 Ultra kit; An in vitro diagnostic medical device (IVD)

REF: 2 pack - 07293184 (110312) and 6 pack - 0790714 (110313)

Multiple Lot Numbers

Supplied with:

ADVIA Centaur BNP kit
REF: 02816634 and 02816138

ADVIA Centaur TSH-3 Ultra kit
REF: 06491080 and 06491072

Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 30/07/2012
Responsible Entity Siemens Ltd Diagnostics Division
Reason/Issue Siemens Healthcare Diagnostics has confirmed a decrease in onboard dilution recovery when using Multi-Diluent 1 that has been stored on board the ADVIA Centaur and ADVIA Centaur XP systems. This under-recovery has been observed in plasma samples with high BNP and TSH-3 values that require dilution to achieve results within the reportable range on the ADVIA Centaur and ADVIA Centaur XP systems.
Recall Action Recall
Recall Action Instructions Siemens is providing work around instructions for users to follow.
Contact Information 1800 310 300 - Siemens Technical Support Center