| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01502-1 |
| Product Name/Description |
Spaplus Weekly wash Protocol and Bottles. An in vitro diagnostic medical device (IVD)
Item Number: TBSIK050S
Lot Number: 415451
ARTG Number: 201721 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
12/12/2017 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer, The Binding Site, have identified that the barcode label for the affected lot is incorrect and will not be recognised by the SPAPLUS instrument. This lot number cannot be used to complete the weekly wash. There is no clinical impact associated with this issue |
| Recall Action |
Recall |
| Recall Action Instructions |
In Vitro Technologies is advising users to quarantine and dispose of any remaining units of the affected product.
This action has been closed out on 6/09/2018. |
| Contact Information |
1300 552 003 - In Vitro Diagnostic |