| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-01139-1 |
| Product Name/Description |
Non Buffered Formalin. An in vitro diagnostic medical device (IVD)
Lot Numbers: 1507197760 and 1510204500
ARTG Number: 244174 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
19/11/2015 |
| Responsible Entity |
|
| Reason/Issue |
Investigations have confirmed that certain lots of Non Buffered Formalin have had incorrect labelling placed on the bottles. The bottles have been labelled as 10% Neutral buffered formalin, rather than Non buffered formalin. This issue is unlikely to cause adverse health consequences. |
| Recall Action |
Recall |
| Recall Action Instructions |
Thermo Fisher is advising the users to inspect stock and quarantine the affected units prior to their return to the sponsor. This action has been closed-out on 18/08/2016. |
| Contact Information |
02 8817 4279 - Thermo Fisher |