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Type of Product	Medical Device
TGA Recall Reference	RC-2017-RN-00645-1
Product Name/Description	Dynabeads HLA Class II and Dynabeads HLA Cell Prep II. An in vitro diagnostic medical device (IVD) Dynabeads HLA Class II Catalogue Number: 21003 Lot Numbers: 00461955, 00477414, 00480193 Catalogue Number: 21004D Lot Numbers: 00461951, 00469604, 00477401, 00480209 Dynabeads HLA Cell Prep II Catalogue Number: 21903 Lot Number: 00469606, 00477408, 00480204 Catalogue Number: 21904 Lot Numbers: 00455989, 00461965, 00469615, 00492942
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	22/05/2017
Responsible Entity	Bio-Strategy Pty Ltd
Reason/Issue	The manufacturer has recently identified an impurity (bacterial endotoxins) in the raw material used for the final formulation of the finished product of Dynabeads HLA Class II and Dynabeads HLA Cell Prep II. Their investigation determined that the presence of these endotoxins along with any deviation from the recommended cell isolation temperature in the user manual (e.g. performing some steps or storing product at room temperature) may reduce cell viability and lead to failure of the negative control.
Recall Action	Recall
Recall Action Instructions	Bio-Strategy are advising users to discontinue use of the affected material immediately, and to quarantine and place all unused product in a box at ambient temperature ready for collection. Bio-Strategy will arrange for the collection, and will provide replacement product or issue credit.. This action has been closed out on 19/10/2018
Contact Information	1800 008 453 - Bio-Strategy