| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-01262-1 |
| Product Name/Description |
UCFP Flex Reagent Cartridge (Urinary / Cerebrospinal fluid protein assay) used with Dimension Vista Systems. An in vitro diagnostic medical device (IVD)
Catalogue Number: K3026
Siemens Material Number: 10445168
Lot Number: 11349BB
An in vitro diagnostic medical device (IVD) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
14/12/2012 |
| Responsible Entity |
|
| Reason/Issue |
Siemens Healthcare Diagnostics has confirmed an increase in the rate of absorbance errors with the Dimension Vista Urinary/Cerebrospinal Fluid Protein (UCFP) Flex reagent cartridge lot 11349BB during calibration. |
| Recall Action |
Recall |
| Recall Action Instructions |
The sponsor is asking users to discontinue and dispose of the affected product. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |