| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01004-1 |
| Product Name/Description |
ADVIA Centaur/Centaur XP/Centaur CP Systems HBc Total (HBcT) Assay
Catalogue Number: 07566733
Siemens Material Number (SMN): 10309508
Kit lot numbers: 36217064, 36281064, 36449064, 37406064 and 38177064
Expiration Date: February 10, 2015
AUST L number: 93126
An in vitro diagnostic medical device (IVD) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
17/09/2014 |
| Responsible Entity |
|
| Reason/Issue |
Siemens Healthcare Diagnostics has confirmed increased assay imprecision and a positive bias (increase in index values) in the low end of the assay with the ADVIA Centaur Systems HBc Total (HBcT). The increased imprecision and positive bias is observed with patient samples and negative controls and can result in an increase in false reactive results.
The increase in the number of false reactive results may cause additional testing but should not result in the reporting of an increased number of false positive results to physicians. The Instructions For Use (IFU) recommends that clinical interpretation be made in conjunction with other HBV serological markers. |
| Recall Action |
Recall |
| Recall Action Instructions |
Siemens is asking customers to discontinue use and discard the affected kit lots. Customers are advised to review the letter with their Medical Director. This action has been closed-out on 18/04/2017. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |