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Type of Product	Medical Device
TGA Recall Reference	RC-2012-RN-01135-1
Product Name/Description	Multiple assays used with ADVIA Centaur, ADVIA Centaur XP, ADVIA Centaur CP Systems: Theophylline 2, Procalcitonin, Folate, DHEA-SO4, CA 19-9, BR Assay for CA 15-3, BR Assay for CA 27.29, BNP (B-type Natriuretic Peptide), In vitro diagnostic medical devices (IVDs) Theophylline 2 ARTG: 175699 Procalcitonin, DHEA-SO4 ARTG: 175698 Folate ARTG: 175700 BR Assay for CA 15-3, CA 19-9, BR Assay for CA 27.29 ARTG: 175636 BNP ARTG: 175075 Multiple SN and REF Numbers
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	8/11/2012
Responsible Entity	Siemens Ltd Diagnostics Division
Reason/Issue	The operating range of the ADVIA Centaur systems is 18°C to 30°C. The affected assays can product inaccurate results when performed within this operating range. A change in room temperature may increase or decrease assay results, depending on the specific assay and ADVIA Centaur system used. This phenomenon is observed when assay results are reported at a temperature different from the temperature at which the assay was calibrated. Depending on the frequency of quality control testing and laboratory temperature at the time quality controls are tested, this issue may not always be detected through routine quality control monitoring.
Recall Action	Recall for Product Correction
Recall Action Instructions	Customers are being advised to immediately implement the revised room temperature operating ranges for the ADVIA Centaur, ADVIA Centaur XP, and ADVIA Centaur CP assays
Contact Information	1800 310 300 - Siemens Customer Care Centre