| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00303-1 |
| Product Name/Description |
ADVIA Chemistry Systems - Urea Nitrogen (UN). An in vitro diagnostic medical device (IVD)
Catalogue Number: 03040257
Lot Numbers: 408143, 418290
Expiry (both lots): 28/06/2018
ARTG Number: 176642
Siemens Healthcare - Clinical chemistry substrate IVDs |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
6/04/2018 |
| Responsible Entity |
|
| Reason/Issue |
Siemens Healthcare Diagnostics has confirmed that the Urea Nitrogen reagent kit lots 408143 and 418290 for use on ADVIA 1800, 2400 and XPT Chemistry Systems are failing to perform as intended due to microbial contamination of a bulk reagent during the manufacturing process. This may demonstrate as an increased incidence of Calibration Failures. Results cannot be generated by the system when calibration fails.
If calibration passes, there is a potential for falsely elevated patient and quality control results.
Internal testing has also shown that for the affected lots, results have the potential to be falsely increased by approximately 10 mg/dL (3.57 mmol/L) across the analytical range. Quality controls may not always detect the elevated results. |
| Recall Action |
Recall |
| Recall Action Instructions |
Siemens is advising customers to discontinue use of and discard affected kit lots. A replacement for discarded units will be provided.
This action has been closed out on 10/02/2021 |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |