| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00111-1 |
| Product Name/Description |
ADVIA Chemistry 1800 and 2400 Instructions For Use (IFU) Updates. An in vitro diagnostic medical device (IVD)
Multiple Siemens material numbers
ARTG number: 175890 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
10/02/2015 |
| Responsible Entity |
|
| Reason/Issue |
Siemens Healthcare Diagnostics has determined through an internal investigation that some assays do not align with the representative data published in the Instructions For Use (IFU) for On-board Stability, Calibration Frequency, and/or Interference. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is requesting their customers to verify that the current IFU version for methods in use in the laboratory is being followed. Navigate to the Siemens Document Library for the current version of the IFU: https://www.healthcare.siemens.com/doclib. For on-board stability and calibration frequency changes, ensure that the ADVIA Chemistry system is programmed to reflect the changes indicated in the IFU. This action has been closed-out on 03/08/2016. |
| Contact Information |
1800 310 300 - Siemens Technical Support Center |