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Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-00275-1
Product Name/Description	Captia Malaria EIA Catalogue Number: 2622471 Lot Number: 005
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	27/03/2015
Responsible Entity	Inverness Medical Innovations Australia Pty Ltd T/A Alere
Reason/Issue	While conducting a review of the documentation for the above mentioned kit it was discovered that an incorrect box top label and barcode were used on this lot number. The box top label contains reference to the detection of antibodies to P. falciparum, P. vivax, P. ovale, and P. malariae. The correct box top label statement should include the detection of P. falciparum and P. vivax only. Also, the barcode label contains the incorrect GTIN code of (01)05391516745130. The correct GTIN code for this product is (01)05391516745147.
Recall Action	Recall for Product Correction
Recall Action Instructions	Alere is notifying their customers that the labels should only reference detection of antibodies to P. falciparum and P. vivax. Customers are assured that the instructions for use provided in the kits are correct. This action has been closed-out on 04/08/2016.
Contact Information	07 3363 7711 - Alere Technical Support