| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-01138-1 |
| Product Name/Description |
ADVIA Centaur/Centaur XP/ Centaur CP HBcTotal (HBcT) Kits. An in vitro diagnostic medical device (IVD)
Siemens Material Number: 10309508
Product Number: 07566733
Multiple lot numbers affected
ARTG Number: 93126 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
8/11/2012 |
| Responsible Entity |
|
| Reason/Issue |
Siemens Healthcare Diagnostics has received complaints regarding a perceived increased rate of reactive results that do not correspond with other HBV serological markers. Reagent lots ending in 044, 045 and 046 do not meet the specificity claims of 99.75% (5130/5143) with a 95% confidence interval (CI) of 99.57 to 99.87% as described in the Instructions for Use (IFU) for the HBcT assay when used on ADVIA Centaur systems. |
| Recall Action |
Recall |
| Recall Action Instructions |
Discontinue and discard affected lots. Affected lots will be replaced by Siemens Ltd. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |