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Type of Product	Medical Device
TGA Recall Reference	RC-2012-RN-01072-1
Product Name/Description	Bio-Rad Multispot HIV-1 / HIV-2 Rapid Test. An in vitro diagnostic medical device (IVD) Catalogue Number: 25228 Reagent Kit Lot Number: 114284 Conjugate Lot number: 114280 ARTG Number: 53509
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	23/10/2012
Responsible Entity	Bio-Rad Laboratories Pty Ltd
Reason/Issue	Bio-Rad Laboratories has received reports of decreased reactivity accompanied by a faint speckling appearance on cartridge membranes when using some vials of Conjugate in the Multispot HIV-1 / HIV-2 Rapid Test.
Recall Action	Recall
Recall Action Instructions	Bio-Rad are recalling all affected lots and recommending the retesting of patient samples reported as negative under certain circumstances and at the discretion of the Laboratory Director.
Contact Information	1800 224 354 - Bio-Rad Laboratories