| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01323-1 |
| Product Name/Description |
Alere Actim Partus. An in vitro diagnostic medical device (IVD).
Catalogue Numbers: 31930ETAL, 31931ETAL, 31931ETAC
Multiple batch numbers affected
ARTG Number: 202704 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
16/12/2014 |
| Responsible Entity |
|
| Reason/Issue |
Certain batches of Actim Partus dipsticks (used in the management of suspected preterm delivery) have shown increased non-specific binding during late stages of the 24 month shelf-life of the product.
This issue increases the risk of false-positives results. The issue does not affect negative results which are still valid. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Replacement stock will be available by the end of January 2015. In the interim, customers are advised to check inventory and amend the expiry date on the primary container to reflect the new expiry date provided in the customer letter. This action has been closed-out on 07/07/2016. |
| Contact Information |
07 3363 7711 - Alere Technical Support |