| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-01033-1 |
| Product Name/Description |
Human Total 25-OH Vitamin D IVD ELISA Kit. An in vitro diagnostic medical device (IVD).
Item number: RDKAP1971
Lot number: 150601
ARTG Number: 251953 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
3/11/2015 |
| Responsible Entity |
|
| Reason/Issue |
The supplier has advised they are not authorised to supply the kit outside of the US, however there is no health risk associated with use of the kit. |
| Recall Action |
Recall |
| Recall Action Instructions |
In Vitro Techologies is advising users to stop using the product and discard any remaining stock, for credit. This action has been closed-out on 07/03/2016. |
| Contact Information |
1300 552 003 - Regulatory invitro |