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Type of Product	Medical Device
TGA Recall Reference	RC-2016-RN-01552-1
Product Name/Description	Quinn’s Advantage Medium with Hepes (In vitro fertilisation culture medium) Product Code: ART-1023 Lot Number: 16280126 Expiry Date: 14 July 2017 ARTG Number: 151263
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	6/12/2016
Responsible Entity	Origio Australasia Pty Ltd
Reason/Issue	ORIGIO a/s has received two complaints regarding what appear to be particles, objects or growth in two bottles of the media. The media showed evidence of particulate matter, cloudiness, and was mis-coloured. To eliminate the risk of microbial contamination, ART-1023, Lot number 16280126 is being recalled.
Recall Action	Recall
Recall Action Instructions	Origio is advising users to return unused affected product. Origio will provide either replacement stock or issue credit for returned unused stock. This action has been closed-out on 09/06/2017.
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