| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01344-1 |
| Product Name/Description |
Human sTfR Quantikine IVD ELISA Kit (used as indicator of iron status). An in vitro diagnostic medical device (IVD).
Catalogue Number: RDSDTFR1
Lot Numbers: 339307 & 334184
Expiry: 16 Jan 2017
ARTG Number: 238312 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
20/10/2016 |
| Responsible Entity |
|
| Reason/Issue |
Recent testing indicates the results of the controls in the kit lot may be out of range ‘high’, invalidating results from patient samples. |
| Recall Action |
Recall |
| Recall Action Instructions |
In Vitro Technologies is advising customers to stop using kits from the affected lots for measuring Human sTfR for diagnostic purposes in patient samples and to discard all unused kits or kit components.
This action has been closed out on 07/11/2018 |
| Contact Information |
1300 552 003 - In Vitro Technologies |