| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00831-1 |
| Product Name/Description |
ADVIA Chemistry Theophylline_2 Reagent
Test Code: THEO_2
Catalogue Number: 10377503
Lot Number: 334018
Expiration Date: Sept 2017
ARTG Number: 175699
An in vitro diagnostic medical device (IVD) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
27/06/2016 |
| Responsible Entity |
|
| Reason/Issue |
Siemens Healthcare Diagnostics has identified that the ADVIA Chemistry Theophylline_2 (THEO_2) reagent lot 334018 used on the ADVIA 1200, 1800, 2400, and XPT Chemistry Systems may exhibit increased imprecision for commercially available TDM quality controls and patient specimens.
Siemens internal investigation after one internal complaint was received confirmed that reagent lot 334018 is not in statistical alignment with the representative precision data published in the IFU and the Design Input Requirements on the ADVIA Chemistry systems.
Discordance with the clinical presentation is expected to lead to repeat testing or more frequent monitoring. There may be a delay in theophylline testing due to troubleshooting after failed QC. |
| Recall Action |
Recall |
| Recall Action Instructions |
Siemens is advising users to discontinue use of and discard the kit lot. Siemens is recommending that a review of previously generated results is considered.
This action was closed out on the 14/09/2018 |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |