| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00629-1 |
| Product Name/Description |
EmbryoScope Time-Lapse Incubator
Reference Numbers: ESD20000, ESD200000-EU, ESD200000-JAP |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
16/07/2014 |
| Responsible Entity |
|
| Reason/Issue |
When cleaning or disinfecting parts of the EmbryoScope time-lapse incubator, the metal clips which are attached to the embryo chamber and support the transparent plate positioned over the culture dish holder may come loose. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
FertiiTech has updated the User Manual to include information on checking that the metal clips are in the correct position after cleaning. This amendment has been notified to end users.
This action was undertaken prior to notifying the Therapeutic Goods Administration. |
| Contact Information |
03 9822 5911 - Gytech Pty Ltd |