| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01206-1 |
| Product Name/Description |
Dimension Vista Systems - Theophylline (THEO) Flex Reagent Cartridge. An in vitro diagnostic medical device (IVD).
Catalogue Number: K4071
Lot Number: 14148AC
ARTG Number: 182220 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
13/11/2014 |
| Responsible Entity |
|
| Reason/Issue |
Siemens Healthcare Diagnostics has confirmed abnormal reaction flags (E145: Abnormal Reaction) with Dimension Vista Theophylline (THEO) Flex reagent cartridge lot 14148AC. The abnormal reaction flags can occur on calibration, QC and/or patient samples. Any result with an abnormal reaction flag is deemed non-reportable as described in the Dimension Vista Operator’s Guide.
The potential for an abnormal reaction flagged result when using the affected lots would prevent reporting theophylline values. The frequency of obtaining abnormal reaction flags as a result of this issue is variable among customer sites ranging from 0 flags to 100% of results flagged. |
| Recall Action |
Recall |
| Recall Action Instructions |
Siemens is requesting their customers to discontinue use and discard any remaining inventory of Dimension Vista THEO lot 14148AC. Siemens will replace any unused inventory of the affected lot at no charge. This action has been closed-out on 02/03/2016. |
| Contact Information |
1800 310 300 - Siemens Technical Support Center |