| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00998-1 |
| Product Name/Description |
Enzygnost Anti-VZV/IgG
(For in vitro diagnostic use in testing to provide information about infection with or exposure to the Varicella zoster virus (VZV)
Catalogue Number: OWLT15
Material Number: 10446625
Lot Number: 44218, 44309, 44565, 45077
ARTG Number: 203348 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
14/10/2015 |
| Responsible Entity |
|
| Reason/Issue |
Enzygnost Anti-VZV/IgG lots can show a higher variation in homogeneity. |
| Recall Action |
Recall |
| Recall Action Instructions |
Siemens is requesting their customers to discontinue use and discard all affected lots of Enzygnost Anti-VZV/IgG. This action has been closed-out on 18/04/2017. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |