| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01315-1 |
| Product Name/Description |
Captia Malaria EIA (An in vitro Diagnostic Medical Device (IVD))
Catalogue Number: 2622471
Lot Number: 005
ARTG Number: 78747 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
16/12/2014 |
| Responsible Entity |
|
| Reason/Issue |
It has been determined that the stop solution that was supposed to have been filled at a 30 mL volume had only been filled at a 25 mL volume. This could result in running out of stop solution when using automation. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Alere is sending their customers a second bottle of correctly labelled stop solution for each kit supplied. In the interim, end users are advised to ensure that there is sufficient stop solution to complete the run prior to sample set-up. This action has been closed-out on 06/07/2016. |
| Contact Information |
07 3363 7711 - Alere Technical Support |