| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00489-1 |
| Product Name/Description |
Hydrochloric Acid 6 Molar 30mL Containers. An in vitro diagnostic medical device (IVD)
Catalogue Number: FNNHCL/30
Lot Numbers: 1708249410 and 1803258790
ARTG Number: 243713
(Thermo Fisher Scientific Australia - Specimen receptacle IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
17/05/2018 |
| Responsible Entity |
|
| Reason/Issue |
Thermo Fisher Scientific has identified that the Plain Container patient information label adhered to specimen jars for specific lots is incorrect as it contains the phrase "10% Neutral Buffered Formalin". The correct label is exactly the same, but without the "10% Neutral Buffered Formalin" phrase.
The product information on the box (contains the containers) and content label on the containers are correct. |
| Recall Action |
Recall |
| Recall Action Instructions |
Thermo Fisher is advising customers to identify and quarantine affected product. Thermo Fisher will contact users to arrange replacement or credit of stock.
This action has been closed out on the 20/11/2018. |
| Contact Information |
03 9757 4300 - Thermo Fisher |