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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 Inverness Medical Innovations Australia Pty Ltd T/A Alere
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